Semantic search
Jump to navigation
Jump to search
| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 49049 | 17 May 2013 04:00:00 | Agreement State | Massachusetts Agreement State Report - Medical Event Concerning Gamma Knife Therapy | A patient was undergoing a second gamma knife treatment when the treatment was delivered to the wrong side of the brain. The patient and the prescribing physician were informed. The patient received 75 Gy to the brain. No serious effects are expected. The Commonwealth of Massachusetts will be providing an update to this event. 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.
The following report was received via email. Event Occurred on 5/17/2013 at approximately 1000 (EDT). With a Gamma Knife Manufacturer: Leksell Gamma System Model: Model 24001 Type C Sealed Sources information: Manufacturer: Elekta Model number: 43685 Prescribed treatment was for one fraction (the daily dose) of 75 Grays to be delivered to the left side of brain. However, the right side of the brain received the treatment. Notified R1DO (Gray) and FSME EVENTS RESOURCE via email. | ||
| ENS 50832 | 10 February 2012 05:00:00 | Agreement State | Agreement State Report - Medical Overdose | The following report was received via e-mail: During a routine inspection, an Agency (Massachusetts Radiation Control Program) inspector identified a past possible gamma stereotactic radiosurgery (GSR also known as gamma knife) medical event that occurred on February 10, 2012 and had not been reported by the licensee. The licensee's written directive was incomplete. Page three of the written directive that described plug placement in the helmet used for treatment was not printed. As a result of the missing information, sixteen gamma knife plugs were not placed in position as intended and instead collimators were placed, the same size collimators used for the remaining plug pattern. Consequently, the patient received an 8.8% overdose to the treatment site. Based on the initial exposure determination to the treatment site by the licensee, the licensee concluded this was not a reportable medical event. However, the dose to tissue other than the treatment site exceeded 0.5 Sv (50 rem) and 50% of the dose expected from the administration defined in the written directive. This is a reportable medical event in accordance with 105 CMR 120.594(A)(1)(c). The dose to tissue other than the treatment site, tissue located beneath the skin and each of the sixteen collimators was calculated to be 71 rem, and greater than 50% of the dose expected from the administration. The dose expected to the tissue, tissue beneath the skin other than the treatment site from the administration defined in the written directive was expected to be less than 710 mrem. The gamma knife, a Leksell Gamma System model 24001 Type C device contained 201 Elekta model 43685 sealed sources totaling approximately 2,519 total curies of cobalt-60 on the date of the event, February 10, 2012. The licensee reported that the authorized user determined that the plug omission error would have no significant detrimental effect on the outcome of the treatment or patient condition and that no further action was necessary in the care of the patient. The licensee reported that that the authorized user reported the event in detail to the patient and provided a written description to the referring physician. The Agency issued notice of violations to the licensee and the licensee described its corrective actions in its response to the notice of violations. Corrective action: The licensee reported that following the omission of the plugs, the Radiation Oncologist Authorized User would designate on page 1 of the written directive if plugs were used and that this would alert the treatment team to identify and implement the appropriate plug pattern; that the licensee replaced the model 24001 Type C gamma knife with a model Perfexion gamma knife that does not use plugs; and that written directive printouts now contain both the individual page number and the total number of pages in the written directive. 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 55557 | 2 November 2021 17:25:00 | Agreement State | Y-90 Microsphere Medical Event | The following information was received from the Commonwealth of Massachusetts via email: On November 2, 2021, 3:00 PM (EDT), licensee reported medical event under license 60-0160 for Sirtex Wilmington LLC SIR-Spheres Y-90 microspheres (SS&D MA-1229-D-101-S) emerging technology for total administered activity that differed from prescribed treatment activity as documented in the written directive by 20 percent or more. A portion of a Y-90 5 mCi microsphere therapy treatment delivered to patient liver on November 2, 2021 remained in the delivery system causing delivery of approximately 3.67 mCi Y-90 of the prescribed 5 mCi. The error was discovered immediately after treatment. Administered dose to treatment area differed from prescribed dose by approximately 27 percent. Licensee stated the cause, including possible equipment malfunction, has not yet been determined. Prescribing physician, referring physician and patient have been notified. Licensee stated no negative health effects to patient due to situation. No additional Y-90 therapy treatment would be required due to this situation. Licensee stated all Y-90 was accounted for. Licensee stated 5 mCi prescription was unusually small compared to previous procedures (range 9-to-39 mCi with 15 mCi being the most prescribed dose). Licensee to submit written report within 15 days of discovery date. This is a next day reportable medical event per regulation. Investigation ongoing. Agency considers this event docket to still be OPEN. Report by Anthony Carpenito, 11/3/2021. | ||
| ENS 56440 | 29 March 2023 02:30:00 | Agreement State | Dose Above Prescribed Dose | The following information was provided by the Massachusetts Radiation Control Program (MA RCP) via email: On 3/29/2023 at 1353 EDT, the Radiation Safety Officer (RSO) at Tufts Medical Center reported a medical event, misadministration, to the MA Radiation Control Program. On 3/28/2023 at 2230 EDT, the licensee discovered that a patient was administered, on the same date shortly before the discovery, a therapeutic activity of 37.9 mCi of Y-90 microspheres to the right lobe of the liver instead of the intended total of 11 mCi in a two-step successive administration per written directive. The patient and the referring physician have been notified. It was reported by the RSO that the administering physician determined that there will be no adverse effect to the patient as a result of the event. The cause of the event has initially attributed to human error by the administering technologist. The error was the improper application of a dose calibrator correction factor for the administration of Y-90 microspheres. A correction factor of 10 was not applied as per procedure. As a result, the technologist drew an activity of 60.3 mCi into the vial instead of 6.03 mCi as per the written directive for the first dose in an intended two step successive administration up to 11 mCi. The actual stasis administration was 37.9 mCi, which is the portion actually delivered to the right lobe of the liver via the delivery apparatus resulting in overloading. No further administrations to the patient occurred. At 1538 EDT on 3/29/2023, the Tufts RSO was contacted to discuss the facility's immediate corrective action. MA RCP recommended that the technologist responsible for the event not be allowed to perform any further therapeutic or diagnostic procedures at this time due to their failure to follow procedures (written directive). The Tufts RSO agreed. It was also agreed that he would contact the administering physician and forward the request for the dose conversion from mCi to rads or Grays to the target tumor. Tufts will provide any additional immediate corrective actions and the delivered dose estimate to the Radiation Control Program in a preliminary summary report on 3/30/2023. MA Event Number: TBD 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. |