FDA Adverse Event Injury Summary report: N

SEQUENCER

MDR report key: 876211 · Received July 9, 2007

Report

Report Number
2950347-2007-00002
Event Type
Injury
Date Received
July 9, 2007
Date of Event
April 11, 2007
Report Date
July 6, 2007
Manufacturer
IMPAC MEDICAL SYSTEMS, INC.
Product Code
KPQ
PMA / PMN Number
K981313
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
GA, US
Reporter Occupation
PHYSICIST

Narratives

Description of Event or Problem · 1

A PATIENT WAS TREATED WITH A HIGHER THAN INTENDED DOSE OF RADIATION DURING A RADIATION THERAPY TREATMENT. THE PATIENT WAS TREATED WITH 291 MU INSTEAD OF THE PRESCRIBED 184 MU FOR ONE TREATMENT FIELD. THE USER NOTED THE DISCREPANT TREATMENT RECORDING AND CONTACTED IMPAC FOR ASSISTANCE. IMPAC INVESTIGATED AND DETERMINED THAT THE EVENT WAS CAUSED BY THE FOLLOWING USER ERRORS (WHICH HAVE BEEN EXPLAINED TO THE SITE): IT APPEARS THAT THE THERAPISTS DID NOT CLEAR THE PREVIOUS PATIENT'S TREATMENT FROM THE LINEAR ACCELERATOR CONSOLE (NOT AN IMPAC PRODUCT). THE THERAPISTS OVERRODE THE INITIAL MU TO BE TREATED FOR 291 MU, THE PREVIOUS PATIENT'S TREATMENT FIELD DOSE, WHICH BECAME THE NEW EXPECTED MU. THEY THEN KEYED OFF THE CONSOLE, MODED THE MACHINE TO DELIVER THE INTENDED 184 (THE CORRECT DOSE) AND TREATED. UPON CONCLUSION, THEY RECEIVED A "MU LESS THAN EXPECTED. DO YOU WANT TO DELIVER THE REMAINDER?" NOTIFICATION, TO WHICH THEY ERRANTLY ANSWERED YES AND DELIVERED THE UNINTENDED ADDITIONAL DOSE (WHICH THEY HAD ALREADY ACCEPTED BY THE OVERRIDE).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SEQUENCER RECORD AND VERIFY SYSTEM KPQ IMPAC MEDICAL SYSTEMS, INC. NA NA

Patients

Seq Age Sex Outcome Treatment
1 YR Other RADIATION THERAPY TREATMENT SYSTEM (MANY DEVICES)