Semantic search
| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 49649 | 21 November 2013 05:00:00 | Agreement State | Agreement State Report - Hdr Brachytherapy Source Placed Incorrectly | Description of incident: HDR brachytherapy treatment of the bronchial, tracheal area. The source was placed incorrectly, resulting in underdose to intended treatment area. An additional treatment fraction will be prescribed to compensate for underdose to intended treatment area. Underdose was discovered on 1st of 3 fractions, prior to delivery of 2nd fractions. Sequelea: No adverse effects expected as a result of medical event, since the patient is terminally ill. 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 47393 | 29 June 2011 04:00:00 | Agreement State | Overdose to Patient of 48% During Gammamed High Dose Rate Treatment | Patient was treated intraoperatively following surgical removal of a metastatic lesion in the sacral region. Treatment involved Ir-192 in a Gammamed HDR (High Dose Rate). In standard cases implant geometry calls for a single-plane treatment, and entry of treatment plan into a commercial planning treatment system to control stopping positions of dwell times of source catheter. Size of treatment volume was such in this case that two treatment planes were required. Decision was made to select a single plane midway between the two treatment planes so that both treated regions would receive required dose. Prescribed dose was 15 Gray at a position 1cm away from the source plane on either side, thus simulating a volume source implant. Treatment plan in this case required manual input of treatment parameters. Physicist incorrectly entered distance between treatment planes as 3 cm, instead of 3 mm. A treatment plan was generated using the larger distance, and corresponding source stopping positions and dwell times for this separation. The result was incorrectly large dwell times and an overdose to the two treatment planes separated in fact by 3 mm. It was calculated that the dose delivered was 22.2 Gray rather than the prescribed 15 Gy, an overdose of 48%. Discovery of Event: Event was discovered during chart rounds when a supervising physicist noticed the difference between prescribed dose and the iCheck results. After discovery of the event, it became evident upon reconstructing the timeline of events that treatment planning sheets in the patient's record had been altered. Effect on Patient: In the opinion of the attending radiation oncologist, it is unlikely that there will be any medical consequences. Root Cause of Event: An analysis concluded that the root cause of the event included:
Actions Taken to Prevent Recurrence of Event:
Inspection Results: An inspector from the Office of Radiological Health conducted an inspection on 9/21/11. The inspector found the circumstances of the event to be as described above. In addition, the inspector found that:
The inspector found licensee to be highly cooperative and believes that actions taken in the wake of this event were satisfactory. No formal violation was issued. 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 46963 | 6 October 2009 04:00:00 | Agreement State | Medical Underdose During Bone Radiation Therapy | The following report was received via e-mail: A patient was treated in the nuclear medicine department on October 6, 2009 with Quadramet (Sm-153 EDTMP) for bone pain administered by the user. The Nuclear Pharmacy prepared, assayed and dispensed 43.5 mCi of Quadramet. The dose was prepared with a needle attached to a syringe. After administration, the syringe and additional materials were returned to the Nuclear Pharmacy for re-assay to determine the activity remaining in the administering materials. Reassaying is a standard procedure. The assay revealed that 12.7 mCi of the Sm-153 remained in the syringe cap and the needle itself. The administered dose was determined to be 30.8 mCi, an underdose of approximately 30%. (The) attending physician in consultation with the Authorized User agreed not to bring the patient back to add to the dose already administered and to await the result of response. In their opinion, there will be no adverse affect on the patient. The Nuclear pharmacy will review whether a needle needs to be present on the dose syringe when dispensed. Nuclear pharmacy will also investigate availability and use of three-way lock to facilitate flushing of the syringe. An update will be provided when an investigation is done by an inspector from the New York City Office of Radiological Health.
The department inspector investigated the above medical event and determined information to be consistent with the initial report to NRC shown above. In addition, the inspector determined that the licensee has instituted corrective actions which should prevent an occurrence of this type of event in the future. In particular: -The nuclear pharmacy will dispense and calibrate syringe with a cap but without a needle attached; -Three-way stopcocks will be distributed as standard instruments with all Sm-153 doses to facilitate flushing of the syringe; -In annual training/retraining, it will be emphasized that Authorized Users must return syringe setups to the nuclear pharmacy for clarification if any setup is incorrect or appears to differ from that which is required per procedure. No violations were issued following the field inspection. Notified the R1DO (Newport) and FSME (O'Sullivan). 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. |