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ENS 5300710 October 2017 10:35:00The following information was received from the Commonwealth of Pennsylvania via email/fax: Event Description: The licensee reported that on October 6, 2017, while performing a lockout procedure for a major outage, the workers noted that two shutters were stuck in the open position. The shutters were both on Berthold Model LB7410 gauges and contained 300 milliCuries of americium-241 each. Both gauges are located in a pit area within major piping lines and a locked gate. This is an inaccessible area, thus no overexposures have occurred. Both units have been taken out of service and a service provider was contacted and has developed a plan to repair or replace the units if necessary. Cause of the Event: Equipment failure. ACTIONS: The Department (PA Bureau of Radiation Protection) will perform a reactive inspection. More information will be provided upon receipt. Event Report ID No: PA170015
ENS 5270926 April 2017 13:44:00The following information was obtained from the Commonwealth of Pennsylvania via fax: Event Description: The event involved a patient who was scheduled to be treated with 11.87 mCi of Y-90 microspheres (TheraSphere), but only received an estimated 5.07 mCi, or 43% of the prescribed dose. The licensee reported the event to the Department (Pennsylvania Department of Environmental Protection) on April 25, 2017. Initial indication is that there was a faulty connection on the catheter line that allowed a leak to occur. The patient and referring physician were notified the day of the procedure. No Jefferson personnel skin contamination occurred. However, gloves, drapes and the patient's skin were contaminated. The patient was quickly decontaminated with alcohol wipes. All remaining areas were also decontaminated. A skin calculation is currently being completed by the licensee to determine the patient's exposure, if any. No overexposure is believed to have occurred. Cause of the Event: Unknown at this time. Suspected human error. Actions: The Department will perform a reactive inspection. The licensee will update their procedure to include additional checks of the Y-90 administration kit. More information will be provided upon receipt. PA Event Report ID No.: PA170009 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
ENS 5225622 September 2016 11:21:00The following was received from the Commonwealth of Pennsylvania via fax: A Troxler nuclear gauge was hit by an asphalt road compactor while on a temporary job site. Impact rendered the gauge unusable. The area was secured and the licensee Radiation Safety Officer determined that the gauge was not leaking. The gauge was then secured for shipment back to Troxler for possible repair or replacement. There was no exposure to workers or the public. The gauge has been secured for transport to Troxler. The Department (PA Department Bureau of Radiation Protection) was also onsite to verify radiation measurements and perform a reactive inspection. More information will be provided when available. Radionuclides: Cs-137 / Am-241:Be Manufacturer: Troxler Model: 3430 Serial Number: 21864 Activity: 9 mCi (Cs-137) / 44 mCi (Am-241) Event Report ID No: PA 160026
ENS 5216510 August 2016 11:28:00The following was received from the Commonwealth of Pennsylvania via email: On August 10, 2016, the Department (Pennsylvania Bureau of Radiation Protection) was notified by Testing Services, Inc. that a moisture/density gauge had been damaged while on location at a temporary job site. It is reportable per 10 CFR 30.50(b)(2). While at a temporary job site, a Humboldt Model 5001 gauge was damaged and became unusable after being run over by a compactor. A survey of the gauge indicated that the source was still in its shielded position. A leak test sample has been taken and sent for analysis and the gauge has been removed from service and secured. No over exposures have occurred. A service provider has been contacted to see if repairs are possible or if the gauge will be returned to the manufacturer. Radionuclides: Cs-137 and Am-241:Be Manufacturer: Humboldt Model: 5001 Serial Number: 2394 Activity: 11 mCi Cs-137, 44 mCi Am-241:Be The gauge has been securely stored and placed out of service until repairs/return can be accomplished. The Department has scheduled a reactive inspection. More information will be provided when available. PA report # PA160022
ENS 517819 March 2016 14:11:00The following report was received from the Commonwealth of Pennsylvania via email and facsimile: Event Type: Loss of licensed material in a quantity greater than or equal to 1000 times the Appendix C quantities in part 20. Notifications: NRG Energy discovered the event on March 7, 2016, (at their Seward, PA location,) and submitted a report to the Department (Pennsylvania Department of Environmental Protection) on March 9, 2016. This event is reportable as per 10 CFR 20.2201(a)(1)(i). Event Description: On Monday March 7, 2016, while conducting the six month inventory check of the radioactive sources at the Seward Power Plant, one tritium exit sign was found missing. The exit sign was installed above a door located in Seward's Fuel Barn. The last inventory check was conducted September 11, 2015, and the exit sign was present at that time. The exit sign was manufactured by EMERG-LITE and was an Everlite series sign. The sign contained between 9.5 - 11.5 Ci of tritium gas at the time of manufacture and was to be replaced before February 2023. The sign was last known to be in good condition and not damaged. No cause for the missing sign has been identified and no exposures have been recorded at this time. Cause of the Event: Unknown at this time. The plant is currently searching the site and conducting interviews with personnel. Actions: The Department will be following up with the facility for any additional information. The plant is also conducting refresher radiation training to plant personnel. More information will be provided upon receipt. Pennsylvania Event Report ID No: PA160009. THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf
ENS 5175324 February 2016 15:10:00The following information was provided by the Commonwealth of Pennsylvania via fax: Notifications: The non-licensee discovered the event on February 23, 2016 and notified the Ohio Department of Health, who then notified our Department (PA Bureau of Radiation Protection) after normal business hours on the same evening. It is reportable per 10 CFR 30.50(b)(1)(i) and 20.2201(a)(i). Event Description: On Monday, February 22, 2016, a large orphan radium-226 (Ra-226) source of unknown total activity or origin was shredded at the PSC Metals facility in Beaver Falls, PA. The recycled material was then shipped to two different Ohio facilities where it was discovered during an inbound radiation scan on February 23, 2016. Cause of the Event: The Pennsylvania facility was (apparently) not performing outbound gamma radiation surveys on recycled materials. Actions: The contaminated shredder, with gamma radiation levels of over 400 mrem/hr, has been isolated. The locker room, clothes, vehicles and workers have been surveyed and no contamination has been found. The gloves of two workers were found to have contamination. A reactive inspection occurred the evening of the 23rd to survey the entrance/gate area of the Beaver Falls facility, and a full emergency response occurred the morning of February 24, 2016. PA and OH Radiation Control Programs are onsite in their respective states and communicating findings. Surveys of employees, vehicles and equipment are ongoing. The response will continue until isolation and containment of Ra-226 is ensured. A local health physics service provider has also been contracted by PSC to assist with the decontamination operation. More information will be provided upon receipt. Media Attention: None at this time, but OH may issue a Press Release. Event Report ID No: PA160007
ENS 5167121 January 2016 13:06:00The following information was obtained from the Commonwealth of Pennsylvania via facsimile: The roll pin on the shutter handle of a Ronan Engineering gauge broke, most likely due to environmental conditions. The shutter is in the closed position and the gauge is out of service. The licensee plans to contact the manufacturer for repair. No overexposures have occurred. Manufacturer: Ronan Engineering Model: SA1-F37 Serial #: M7255 Isotope: Cs-137 Activity: 10 mCi Cause of the Event: The gauge is located in a harsh and dirty environment. In the past, they designed and installed a cover to shield the gauge. When inspecting the gauge after the event, it was noticed that this cover had fallen off. Actions: A reactive inspection is planned by the Department (Pennsylvania Department of Environmental Protection). More information will be provided upon receipt. PA Report No.: PA160005
ENS 5165715 January 2016 08:55:00The following was received from Pennsylvania via fax: On January 14, 2016, the Department (PA DEP Bureau of Radiation Protection) was notified by Universal Well Services that a malfunction of a roll pin on a shutter handle occurred at the Hop Bottom, Pennsylvania temporary job site. It is reportable per 10 CFR 30.50(b)(2). A roll pin, which holds the shutter handle to the shutter shaft, on an in-line density gauge, became dislodged rendering the gauge unusable. The shutter is in the closed position and out of service awaiting repair from a service provider. No exposures occurred. Radionuclide: Cs-137 Manufacturer: Berthold Model: LB 8010 Serial Number: 10059 Activity: 20 mCi The shutter is in the closed position and the gauge is out of service and secure. There was no other damage to the gauge. A reactive inspection is planned by the Department. PA Event ID # PA160002
ENS 5165314 January 2016 10:31:00The following report was received from the State of Pennsylvania via facsimile: On January 13, 2016, the Department (PA DEP Bureau of Radiation Protection) was notified that a Troxler gauge was damaged while on the job site in Pennsylvania. This event is reportable within 24-hours per 10 CFR 30.50(b)(2). A Troxler gauge was hit with a truck while on a job site. The source rod became detached from the gauge and rendered the gauge unusable. The area was secured and a local service provider was notified to recover the gauge. The gauge was not found to be leaking and was secured for shipment back to Troxler for repair. There was no exposure to workers or the public. Gauge Model: 3440 Test Date: 7/6/2015 Gauge S/N: 18936 A local service provider assisted with retrieval of the gauge. A reactive inspection was performed by the Department. More information will be provided upon receipt. PA Event Report ID No: PA160001
ENS 515907 December 2015 14:39:00The following report was received from the Pennsylvania Department of Environmental Protection via facsimile: On 12/4/2015, a patient was scheduled for a yttrium-90 (Y-90) Sirsphere procedure. The prescribed dose on the written directive was 10 mCi. The ion chamber measurements indicated a delivered dose of 7.72 mCi (-22.8% of prescribed dose). Both the patient and referring physician were notified. No harm is expected to the patient. A reactive inspection is planned by the Pennsylvania Department of Environmental Protection. Pennsylvania Event Report ID No: PA150032 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
ENS 518588 April 2016 14:22:00The following report was received from the Commonwealth of Pennsylvania via email: Notifications: The Licensee notified the Department April 1, 2016 of an event that occurred on April 13, 2015. It was discovered almost a year later upon routine review of written directives at the hospital. It is reportable under 10 CFR 35.3045. Event Description: A Xofigor patient was scheduled for their 6th and final treatment on April 13, 2015. The Authorized User (AU) prescribed 0.98 millicurie (mCi) on the written directive (WD). On the prescription form from the radiopharmacy, the 'dispensed amount' of Ra-223 was labeled as 99.40 microCuries (or 0.0994 mCi). The Nuclear Medicine Technologist measured '0.099 mCi' in the dose calibrator just before injecting the Xofigor into the patient (intravenously). The technologist failed to observe that the AU prescribed an activity of 0.98 mCi making the percent error between the measured vs. prescribed activity at -89.9% based upon what was documented in the WD. The hospital believes the intent of the AU was to prescribe '0.098 mCi' which is a typical dose; however, they cannot directly confirm that with the AU since the AU is no longer employed by Geisinger Health System. Another Geisinger AU who is qualified to prescribe Xofigor confirmed that 0.098 mCi would be the correct amount when calculated from the patient's weight. Consequently, if the intent was to prescribe 0.098 milliCuries, there would be no expected harm to the patient as they received the proper Xofigor activity. Cause of the event: Human error. Actions: None at this time. The licensee will submit a final report which will provide corrective actions. Notifying the patient would serve no beneficial purpose. PA Report #: PA160012 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
ENS 5089816 March 2015 15:10:00The following information was obtained from the Commonwealth of Pennsylvania via email and fax: The Department (Pennsylvania Department of Environmental Protection) received a phone call on March 13, 2015 regarding a lost/missing nuclear density gauge. This event is reportable within 24-hours per 10 CFR 20.2201 (a)(1)(i). The gauge was last used on December 16, 2014 at a job site in New Brighton, PA and discovered missing during the next routine quarterly inventory. The case and lock were both intact inside a locked storage area. There were no signs of forced entry and nothing else was missing. The employee, after being questioned, claims no knowledge of the whereabouts of the gauge. (Gauge) Model: Troxler 3411B Serial #: 8254 Isotope: Cs-137 & Am-241 Activity: 9 mCi Cs-137 and 44 mCi Am-241 The police have been notified. The Department will conduct an in depth reactive inspection. A press release will be issued requesting information from the public. More information will be provided upon receipt. Event Report ID No: PA 150006 THIS MATERIAL EVENT CONTAINS A "LESS THAN CAT 3" LEVEL OF RADIOACTIVE MATERIAL Sources that are "Less than IAEA Category 3 sources," are either sources that are very unlikely to cause permanent injury to individuals or contain a very small amount of radioactive material that would not cause any permanent injury. Some of these sources, such as moisture density gauges or thickness gauges that are Category 4, the amount of unshielded radioactive material, if not safely managed or securely protected, could possibly - although it is unlikely - temporarily injure someone who handled it or were otherwise in contact with it, or who were close to it for a period of many weeks. For additional information go to http://www-pub.iaea.org/MTCD/publications/PDF/Pub1227_web.pdf
ENS 5089716 March 2015 15:05:00The following information was obtained from the Commonwealth of Pennsylvania via email and fax: The Department (Pennsylvania Department of Environmental Protection) was notified of this event on Friday, March 13, 2015. It is reportable within 24 hours as per 10 CFR 34.101(a)(2) and 30.50(b)(2). A 68 curie (Ci) iridium-192 (lr-192) source could not be retracted back into the exposure device. The guide tube had become disconnected when the lr-192 source was in the collimator. The guide tube was not properly connected to the front of the exposure device, therefore preventing the source to be fully retracted back into the device. This event was due to human error. The repair/retrieval was performed quickly by the assistant RSO who received a total of 5 mR during the entire process. A reactive inspection is planned by the (Pennsylvania DEP) regional office. Event Report ID No: PA150005
ENS 5081412 February 2015 10:38:00The following information was obtained from the Commonwealth of Pennsylvania via facsimile: Notifications: The Department (Pennsylvania Department of Environmental Protection) was notified of this event on Wednesday, February 11, 2015. It is immediately reportable as per 10 CFR 35.3045(a)(1)(i). Event Description: A patient was receiving Y-90 Sirtex Sirspheres when the administering device failed and a portion of the dose was lost in the apparatus. The patient received 10.4 mCi, or 58% of the prescribed 17.82 mCi dose. Cause of the event: The device came apart during the procedure and the remainder of the dose was contained in the packaging. Actions: The Department plans a reactive inspection. Pennsylvania Event Report ID No: PA150004 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
ENS 4989211 March 2014 09:40:00The following information was provided by the State of Pennsylvania via email: Event type: (On March 10, 2014), A medical event involving the administration of yttrium-90 (Y-90) SirSpheres which is reportable under 10CFR35.3045(a)(3). Specifically, the licensee reported that an unintended organ received, as of yet, an undetermined dose during a prescribed treatment. Notifications: On March 10, 2014, the Department (PA Department of Environmental Protection) received notification about this medical event. Event Description: The patient underwent a Y-90 microsphere treatment. A gastric ulcer developed seemingly as a result of spheres migrating to the stomach. Cause of the Event: Non-target flow of microspheres through an aberrant hepatic arterial vasculature supplying the stomach. Actions: Details of the event are being developed. Further information will be given when received. The Department plans to do a reactive inspection. PA Report ID NO: PA-140007 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
ENS 4867114 January 2013 14:53:00The following information was obtained from the Commonwealth of Pennsylvania Department of Environmental Protection via e-mail: On January 11, 2013 the licensee informed the Department's Southeastern Regional Office of the Medical Event. The event is reportable within 24 hours per 10CFR 35.3045(a)(1)(i). Both the patient and referring physician were notified. On December 4, 2012 the patient received an iodine-125 prostate seed implant. The patient returned for the 30 day post-treatment follow-up CT scan on January 9, 2013. Upon review of the CT results on January 10, 2013, it was discovered that the prostate received approximately 60% of the intended dose. The D90 was determined to be 56 Gy out of a prescribed dose of 110 Gy. The potential cause of the event was noted as possible organ shift or incorrect depth placement of needles. The licensee plans to compensate for the undertreated area with follow-up external beam therapy. They will provide the Department a written report in 15 days. The Southeastern Regional Office plans to follow up with a reactive inspection. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
ENS 4875214 February 2013 14:28:00The following information was obtained from the Commonwealth of Pennsylvania via email and facsimile: Notifications: On February 13, 2013 the licensee informed the Department's (Pennsylvania Department of Environmental Protection) South-central Regional Office of the medical event. The event is reportable within 24 hours per 10 CFR 35.3045(a)(1)(i). The referring physician was notified of this event but the patient passed away in November of 2012 as a result of metastatic pancreatic cancer. Event Description: During a routine audit of the Y-90 written directive program, an error was noted in a SIR-Sphere procedure that was performed on August 28, 2012. The patient was prescribed 17.6 mCi of Y-90 SIR-Spheres. The patient actually received only 12.8 mCi. This corresponds to a dose that is 27.3% lower than the prescribed dose. Cause of the Event: The physician recorded the wrong administered dose on the written directive form. Also a small liquid volume remained in the vial after the 'air-injection' final step. Actions: The licensee initiated and completed an audit of all SIR-Sphere procedures and no other issues were identified in any other patients since inception of the program. The South-central Regional Office has been in discussion with the licensee regarding corrective actions that will be implemented. Pennsylvania Event Report ID No.: PA130006 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
ENS 4817710 August 2012 13:41:00The following information was provided by the Commonwealth of Pennsylvania via facsimile: On Thursday, August 9, 2012, the licensee informed the Department's (Department of Environmental Protection (DEP)) Southwest Regional Office about the discovery of a shutter failure. It is reportable within 24- hours under 10CFR 30.50(b)(2). During a semi-annual leak test being performed by a consultant, the shutter was found inoperable and stuck in the open position. No dose is believed to have been received by any personnel. The device is identified as: Manufacturer: LFE, Model #: SS-3A, Device Serial #: 300-483L, Sealed Source Model #: SS-3A, Sealed Source SN: 02311, Isotope: Am-241, Activity: (1 Ci). The cause of the event was equipment malfunction. Licensee continued running the mill with permission granted by DEP until the consultant arrived later that same day. Repairs were made to the shutter mechanism, followed by a radiation survey, wipe test, and function check of the gauge. The gauge is now operating properly. DEP scheduled a reactive inspection for August 10, 2012. PA Event Report No. PA120024
ENS 478902 May 2012 15:08:00The following report was received via fax: On April 30, 2012, while on location in North Eastern, PA, an incident occurred which indirectly involved a nuclear density device. While pumping at a well site at 7200 psi, a large section of 4 inch pipe became dislodged at a joint, sending the pipe in the direction of the gauge. This caused a piece of iron to collide with the densitometer which in turn, knocked the in-line densitometer off of the 4 foot, 4 inch piece of iron it was attached to. Gauge Information: Material: Cs-137 Manufacturer: Thermo MeasureTech Sealed Source Model: 57157C Activity: 250mCi The density gauge showed no signs of damage. The device was immediately secured and a trained employee was dispatched to retrieve and properly package and transport the device back to the Blacklick, PA facility. The device was leak tested in the field and surveyed with a Ludlum Model 3. The densitometer is currently in secure storage at the Blacklick facility and is awaiting repair from a licensed service provider. The Department (PA Bureau of Radiation Protection) plans to conduct a reactive inspection on Tuesday, May 8, 2012. PA Event: PA-120014
ENS 4796525 May 2012 14:19:00The following information was obtained from the Commonwealth of Pennsylvania via fax: A patient was undergoing treatment with I-125 prostate seeds on January 20, 2012. The patient was prescribed to receive 110 Gy for a determined prostate volume of 21.08 cc. On March 16, 2012 the patient had a follow up CT scan where the prostate volume was determined to be 47 cc and the D90 to the prostate to be 75 Gy. The oncologist questioned the results and ordered an additional CT scan. On May 16, 2012, a second CT scan was performed to confirm the first CT scan. On May 21, 2012, the radiology oncologist calculated the prostate volume to be 33.59 cc and confirmed the D90 to be 75 Gy. The radiation oncologist has no explanation for the edema. Cause of the Event: Implant performed using ultrasound, post implant verification via CT. Actions: There will be a reactive inspection (by the Commonwealth of Pennsylvania). The radiation oncologist ordered external beam radiation therapy and feels that the total dose is sufficient. Additional follow up with the patient will occur. PA Report ID No.: PA120018 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
ENS 4761020 January 2012 13:59:00The following information was provided by the Commonwealth of Pennsylvania via email: The Department's (PA Bureau of Radiation Protection) central office received an email on January 19, 2012. This event is reportable within 24-hours under 10CFR 30.50(b)(2). EVENT DESCRIPTION: It was determined on January 19, 2012 during the six month shutter check that the remote actuator cables and one handle on four devices are inoperable. The devices are identified as: Manufacturer Model Serial Isotope Activity Texas Nuclear 5197 81624 Cs-137 100 mCi Texas Nuclear 5197 81631 Cs-137 100 mCi Texas Nuclear 5197 81634 Cs-137 100 mCi Texas Nuclear 5197 81635 Cs-137 100 mCi CAUSE OF THE EVENT: Normal wear and tear (30+ year old gauges) ACTIONS: The shutters are in the locked and closed position and shall remain so until qualified repairs can be made. The gauges are planned to be removed and returned to the manufacturer. No employees were exposed to excess levels of radiation as a result of these failures. The Department plans to conduct a reactive inspection. Event Report ID No: PA120003
ENS 474043 November 2011 10:29:00The following was received from the Commonwealth of Pennsylvania via fax: Event type: A medical event (ME) involving Y-90 TheraSpheres where the patient received an under-dose of 63%, which is reportable under 10CFR35.3045(a)(1)(ii). Notifications: On November 2, 2011, at 1550, the Department's Southeast Regional Office received notification via phone message about the ME. Event Description: A patient who was being treated with MDS Nordion Y-90 TheraSpheres, received only 37% of the intended dose based on the before and after survey readings of the TheraSphere accoutrements (5.8mR/hr vs. 3.8mR/hr). The licensee is in the process of notifying the patient. No more information is available at this time. Cause of the Event: The licensee suspects that procedural changes led to the problem. Nordion recently changed the procedure to clamp the priming line with a hemostat because the original clamp is hard to manipulate. This was their first procedure using the hemostat. Actions: Nordion has been contacted. The licensee will be submitting a written report within 15 days. The Department plans to do a reactive inspection. Event Report ID No. PA 110033 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
ENS 473991 November 2011 14:52:00The following information was received by facsimile: On Friday, October 28th, two NVI (Nondestructive and Visual Inspection, LLC) employees were performing radiography on a pipeline project in Wyalusing, PA. While performing radiography on a main line the crew approached the pipe after cranking in the source to set-up and mount for their next shot. While strapping the next weld with film, one of the crew noticed the indicator which shows full retraction of the source on their Amersham Model D880 had not popped out. At this time both crew members confirmed their survey meters read zero. However, also at this point they realized one member's rate alarm was chirping, but not very loudly and the other's rate alarm was not chirping at all. It was noted both rate alarms were inspected and working properly at the beginning of the shift. The crew then approached the crank controls where one was able to make approximately one turn with the crank, fully retracting the source back into the camera. They inspected their dosimeters which were both off-scale. They informed the RSO and were immediately removed from work. The badges were sent for emergency processing and whole body dosimetry results were 5133mR and 1447mR. CAUSE OF THE EVENT: Undetermined at this time, expected faulty equipment. ACTIONS: The licensee will be submitting a written report within 30 days. The Department (PA DEP Bureau of Radiation Protection) plans to do a reactive inspection. Pennsylvania Event Report: PA110032
ENS 4738528 October 2011 16:02:00The following was received from the state via facsimile: The patient took a pregnancy test on October 5, 2011 and the results were negative. The patient was then treated with 73.7mCi of I-131 thyroid therapy treatment on October 6, 2011. The patient discovered she was pregnant and contacted the licensee on October 26, 2011. The estimated dose to the fetus is 17.4 Rads. It has been determined that the fetus was 10 days old when the therapy was given to the patient. The licensee will be submitting a written report within 15 days. The Department plans to do a reactive inspection to review licensee's procedures and response to this ME. Event Report ID No. PA110031
ENS 4728120 September 2011 10:27:00The following information was received from the Commonwealth of Pennsylvania via facsimile: Event Type: A medical event (ME) involving Y-90 Theraspheres where the patient received 51% of the intended dose, which is reportable under 10CFR35.3045(a)(1)(ii). 'Notifications: On September 16, 2011, at 1414 (EDT), the Department's Southeast Regional Office received notification via phone message about the ME. Event Description. The patient was being treated with MDS Nordion Y-90 glass Theraspheres for transarterial radioembolization. A suspected defective catheter caused 49% of the intended dose to clog up in the catheter. No harm to the patient is expected. The referring physician and patient have been notified. No more information is available at this time. Cause of the event: The cause of the event is suspected to be a defective catheter. Actions: After decay, the catheter will be returned to Nordion for inspection and may also be returned to the manufacturer, Terumo Medical, for a defect analysis. The licensee will be submitting a written report within 15 days. The (Pennsylvania) Department (of Environmental Protection) plans to do a reactive inspection. PA Report ID: PA110025 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
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