ENS 53430
ENS Event | |
|---|---|
04:00 May 25, 2018 | |
| Title | En Revision Imported Date 7/13/2018 |
| Event Description | EN Revision Text: AGREEMENT STATE REPORT - PATIENT SKIN CONTAMINATION
The following was received from the Commonwealth of Pennsylvania via email: On May 29, 2018, the Department's [Bureau of Radiation Protection] staff in Central Office became aware of a medical event (ME) at U PENN hospital in Philadelphia. The ME is reportable as per 10 CFR 35.3045(a)(1)(i) and also meets criteria for an Abnormal Occurrence. On May 25, 2018, a 17 year old pediatric patient underwent an 834 millicurie metaiodobenzylguanidine (MIBG) lodine-131 (I-131) treatment for brain cancer. The dose was delivered in a 30 ml syringe and infused via an automatic pump. The nuclear medical technician present during the infusion reported seeing a small amount of blood, but other than that, nothing unusual was noted. However, upon completion of the infusion, meter readings noted high activities on the patient's clothing and bed linen. The possible reason given being a faulty connection line on the automatic pump. The contamination is believed to have also been present on the skin all weekend. Due to the large dose of I-131 infused, the licensee's staff were not able to see the contamination on the patient's skin until he developed erythema. The licensee is in the process of doing a dose reconstruction for the skin contamination. Based on the reading from the patient and estimated activity in the various contaminated items, the licensee currently estimates that approximately 50% of the intended dosage was successfully infused. The authorized user has been informed and is currently notifying the patient's parents and the referring physician. A reactive inspection is planned by the Department. More information will be provided upon receipt. PA Event Report ID No: PA 180012 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 University of Pennsylvania (U Penn) reported that a patient's skin became contaminated during medical treatment on 5/25/2018. The 17-year-old pediatric patient was scheduled to receive 30.86 GBq (834 mCi) of 1-131 metaiodobenzylguanidine (MIBG) for treatment of brain cancer. The dosage was delivered in a 30 ml syringe and infused via an automatic pump. The nuclear medicine technician present during the infusion saw a small amount of blood, but nothing unusual other than that was noted. However, upon completion of the infusion, radiation surveys revealed high activities of 1-131 on the patient's clothing and bed linen. U Penn stated that the patient's upper right thigh was cleaned. On 5/27/2018, the patient reported discomfort and reddening (i.e. erythema) on the skin of his upper right thigh, which developed into a lesion and further into desquamation (grade 3) the next day. Radioactive contamination is believed to have been present on the patient's skin for 24 to 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br />. Based on U Penn measurements, nuclear medicine imaging, and the patient's clinical symptoms, the dose to the skin was estimated to be between 50,000 and 120,000 cGy (rad) to a 15 cm2 area. Radiation safety staff consulted with U.S. DOE's REAC/TS in Oak Ridge TN, to verify dose calculations. Calculations of the activity in the waste and the exposure rate from the patient in previous treatments estimated the activity delivered at 15.54 GBq (420 mCi). It was calculated that approximately 7.77 GBq (210 mCi) went to the waste. The cause of the incident is believed to be a faulty connection line on the automatic pump. The patient was also disconnected from the infusion pump at the 'Spiros tube' to use the lavatory part way through the procedure. Due to the large dosage of 1-131 infused, U Penn staff were unable to detect the contamination on the patient's skin until he developed erythema. The authorized user was informed and notified the patient's parents and referring physician. Pennsylvania DEP, Bureau of Radiation Protection, performed a reactive inspection on 6/7 and 6/13/2018. U Penn is conducting a full root cause analysis to develop and implement corrective actions. Procedures that have already been implemented for 1-131 MIBG patients included placing absorbent chucks between all parts of the infusion line and the patient's body and requiring an authorized user to be contacted for approval if it is necessary to disconnect a patient during the infusion. Root Cause(s): possible equipment failure, training, and/or human error in connecting the line to the infusion pump. Actions: A reactive inspection has been completed by the Department. More information will be provided upon receipt from U Penn. Notified R1DO (Bower), NMSS Events Notification E-mail Group, and INES Coordinator (Milligan). |
| Where | |
|---|---|
| University Of Pennsylvania Philadelphia, Pennsylvania (NRC Region 1) | |
| License number: | Pa-0131 |
| Organization: | Pa Bureau Of Radiation Protection |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+106.8 h4.45 days <br />0.636 weeks <br />0.146 months <br />) | |
| Opened: | John Chippo 14:48 May 29, 2018 |
| NRC Officer: | Steven Vitt |
| Last Updated: | Jul 12, 2018 |
| 53430 - NRC Website
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University of Pennsylvania with Agreement State | |
WEEKMONTHYEARENS 570812024-04-17T04:00:00017 April 2024 04:00:00
[Table view]Agreement State Medical Underdose ENS 566612023-08-05T15:07:0005 August 2023 15:07:00 Agreement State Medical Underdose ENS 570862023-01-31T04:00:00031 January 2023 04:00:00 Agreement State Medical Event ENS 570852022-12-29T04:00:00029 December 2022 04:00:00 Agreement State Medical Event ENS 570842022-12-28T04:00:00028 December 2022 04:00:00 Agreement State Medical Event ENS 558892022-05-04T04:00:0004 May 2022 04:00:00 Agreement State Underdose ENS 558512022-04-18T04:00:00018 April 2022 04:00:00 Agreement State Patient Underdose ENS 553372021-07-02T04:00:0002 July 2021 04:00:00 Agreement State Patient Under Dose ENS 549642020-10-20T04:00:00020 October 2020 04:00:00 Agreement State Missing Licensed Material ENS 534302018-05-25T04:00:00025 May 2018 04:00:00 Agreement State En Revision Imported Date 10/15/2018 ENS 525042017-01-19T05:00:00019 January 2017 05:00:00 Agreement State Agreement State Report - Received Dose Less than Prescribed Dose ENS 524572016-12-20T05:00:00020 December 2016 05:00:00 Agreement State Agreement State Report - Medical Underdose ENS 483032012-09-11T04:00:00011 September 2012 04:00:00 Agreement State Agreement State Report - Patient Underexposure Using Yttrium-90 Sir-Spheres Treatment ENS 482292012-08-23T04:00:00023 August 2012 04:00:00 Agreement State Agreement State Report - Patient Underexposure Using Yttrium-90 Sir-Spheres Treatment ENS 481372012-07-26T04:00:00026 July 2012 04:00:00 Agreement State Agreement State Report - Medical Event Involving an Underdose with Yttrium-90 Spheres ENS 477632012-03-20T04:00:00020 March 2012 04:00:00 Agreement State Agreement State Report - Underdose During Liver Disease Treatment ENS 474352011-11-10T12:00:00010 November 2011 12:00:00 Agreement State Agreement State Report - Underdosage of Theraspheres ENS 461012010-07-07T04:00:0007 July 2010 04:00:00 Agreement State Agreement State Report - Delivered Dose Differed from the Prescribed Dose by Greater than 50% ENS 457272010-01-21T05:00:00021 January 2010 05:00:00 Agreement State Agreement State Report - Brachytherapy Implants Outside of the Intended Treatment Area 2024-04-17T04:00:00 | |