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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 4769816 February 2012 06:00:00Agreement StateAgreement State Report - Misadministration of a RadiopharmaceuticalThe following information was received from the State of Texas via email: On 2/22/12 the licensee notified the Agency (Texas Department of State Health Services) of a medical event that occurred on 2/16/12. The licensee reported that the wrong radiopharmaceutical had been administered to a patient. Tc-99m MAA was administered rather than the prescribed Tc-99m Pertechnitate. During the administration of the wrong drug, an estimated 1/3-1/2 of the dose infiltrated the skin causing an estimated 400 rad exposure subcutaneously. The referring physician and patient have been notified. No signs or symptoms have been observed in the patient as a result of the incident. The estimated exposure is being reevaluated by the licensee. Texas Incident: I-8937 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 4537821 September 2009 05:00:00Agreement StateAgreement State Report- Patient Received Improper Dosage

On September 21, 2009, a patient undergoing mammosite brachytherapy did not receive the proper dose administration due to the Ir-192 (9.6 Ci) source failing to retract. The administering physician retrieved the source from the patient and placed it back in the device. A dose estimate is in progress, however, the licensee does not expect the dosage to exceed 50 percent of the prescribed dose. The afterloader was cleaned recently and the licensee does not expect any debris from the device. The State will report any results of the dose assessment. Texas Incident Number: #8673 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.

  • * * RETRACTION ON 1/27/2010 AT 1703 FROM ANNIE BACKHAUS TO MARK ABRAMOVITZ * * *

The following report was received via e-mail: On September 22, 2009, the Agency (Texas Department of Health) was notified of an incident that occurred on September 21, 2009 involving a patient undergoing mammosite brachytherapy. The patient did not receive the proper dose due to the Iridium (Ir)-192 (9.6 Curies) source failing to retract back into the High Dose Rate after-loader unit. The administering physician retrieved the source from the patient and placed it in a shielded container. An investigation by the Agency was performed on September 29, 2009 and it determined that this was not a reportable event because the fractionated dose delivered differed from the prescribed dose, for a single fraction, by less than 50 percent or the total dose for the prescribed treatment differed from that prescribed by less than 20 percent. Because this does not meet the criteria for a reportable medical event, the State of Texas would like to retract this report. Notified the R4DO (Pick), and FSME (Thaggard).