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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 54346 | 23 October 2019 04:00:00 | Agreement State | Incorrect Brachytherapy Seed Set Used for Implantation | The following information was received via E-mail: The licensee informed the Department (Pennsylvania Department of Radiation Protection) that a brachytherapy seed set was implanted in the wrong patient. It is reportable per 10 CFR 35.3045(a)(2)(iii)(B). On October 23, 2019, the licensee was performing a permanent brachytherapy during which an incorrect prostate brachytherapy seed set (lsoRay Model CS-1) was brought to the procedure room and 6 Cs-131 seeds were implanted into the prostate of a patient. The procedure was stopped immediately when the error was recognized. The correct seeds were then brought to the operating room and the procedure was completed using the correct seeds. Forty Seven (47) seeds, 85 gray, (3.135 mCi) were prescribed and 3.03 mCi given. The Authorized User notified the urologist and patient this morning (10/24/19). No harm is expected to the patient. The cause of the event is unknown at this time. The Department will perform a reactive inspection. More information will be provided as received. Pennsylvania Event Report ID No: PA190024 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 49686 | 27 December 2013 05:00:00 | Agreement State | Agreement State Report - Nuclear Medicine Administered to Wrong Patient | The following Agreement State Report was received via facsimile: Notifications: York Hospital (a PA DEP licensee) left a voice message on Friday, December 27, 2013 after business hours; the voice message was reviewed by the South Central Regional Office on Monday, December 30, 2013. This is an immediate reporting event under 35.3045(a)(2)(iii). Event Description: On Friday, December 27, 2013 a nuclear medicine technologist at York Hospital injected the wrong patient with 500 microcuries (microCi) of indium-111 (ln-111) Oxine leukocyte (ln-111 Oxine WBC or ln-111 WBC). This was to be part of a radiolabeling leukocyte component procedure for another patient that was in an adjacent room. The nuclear medicine technologist noticed swelling at the injection site and notified a nurse. Physicians and patient were informed of the incident on December 27th. Additional information regarding the dimensions of the tissue volume affected by the extravasation has become available from non-nuclear imaging performed subsequent to the ln-111 WBC injection. The shallow dose to the skin was estimated to be approximately 210 rad (2.1 Gy). In addition, a request has been made for approval to conduct follow-up whole body imaging of the residual ln-111 in the patient's body, towards providing additional information utilizable in refining further the shallow and whole body dose estimate. CAUSE OF THE EVENT: Human error. The nuclear medicine technologist did not check the patient's wrist-band, nor did they correlate the name and birth date provided verbally from the wrong patient, as to being not the appropriate patient for the ln-111 WBC injection. ACTIONS: A reactive inspection by the PA DEP South Central Region took place on Monday, December 30th. The nuclear medicine technologist was immediately placed on administration leave by the licensee. Further investigations by PA DEP and the licensee are underway. PA Event Report ID No: PA130030 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 48218 | 21 August 2012 04:00:00 | Agreement State | Agreement State - Radiation Treatment Overdose Resulting from a Potential Generic Issue | The following information was provided by the State of Pennsylvania via facsimile: On Monday, August 20, 2012, the licensee informed the Pennsylvania Department of Environmental Protection's Southcentral Regional Office of a medical event which occurred the same day. It is reportable within 24-hours under 10 CFR 35.3045(a)(1)(iii). During the first fraction of radiation therapy treatment, using a Nucletron Corporation microSelectron HDR (High Dose Rate) Model 106.990 remote afterloader, the unit's treatment planning software malfunctioned, resulting in an overdose to the patient of approximately 76.5%. Facility staff also failed to complete a required worksheet which may have alerted the Authorized User to the dosage difference prior to treatment. A total dose of 600 cGy (rad) was delivered instead of the prescribed 340 cGy (rad). The patient was notified on the same day, while the referring physician was notified the following day. The treating physician anticipates no effect to the patient, however, dose reconstruction is currently in progress. We believe this incident also qualifies the event as an Abnormal Occurrence. Cause of the event is equipment malfunction and human error. Licensee is contacting a service provider for the HDR unit to investigate the incident, and if needed, repair the equipment. The Pennsylvania Department of Environmental Protection will be evaluating possible generic implications and plans to do a reactive inspection as soon as possible. PA Event Report No: PA120025 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. |