MEDFUSION 2001I SYRINGE INFUSION PUMP

Description of Event or Problem

IT WAS REPORTED BY THE BIO-MED TECH AT THE USER FACILITY THAT THE DEVICE "OVERINFUSED." ADD'L INFO WAS REQUESTED AND REC'D FROM THE USER FACILITY'S RISK MANAGER WHO REPORTED THAT THERE WAS NO HARM TO THE PT AND THAT "THE MEDICATION WAS GIVEN AT A FASTER RATE THAN THE PUMP INDICATES SHOULD HAVE BEEN GIVEN." ADDITIONALLY THEY DID PERFORM A SHORT TEST WITH WATER IN THE SYRINGE AND IT APPEARED TO BE WORKING, BUT DID NOT PERFORM ANY LONG TERM TESTING.

Additional Manufacturer Narrative

THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. AN ATTEMPT WAS MADE TO OPERATE THE PUMP TO TEST THE DELIVERY ACCURACY, THIS WAS NOT POSSIBLE DUE TO NUMEROUS ISSUES WITH THE DEVICE. THE TAMPER STICKER WAS NOT INTACT, THE DEVICE HAD BEEN SERVICED IN THE FIELD AND THERE WERE MULTPLE INDICATIONS THAT THE PUMP WAS NOT REASSSEMBLED CORRECTLY. ADDITIONALLY, THERE WAS PHYSICAL DAMAGE AND FLUID INGRESSION AND THE DEVICE WAS OUT OF CALIBRATION. THE DEVICE WAS EVALUATED AND THE ALLEGED FAILURE COULD NOT BE DUPLICATED AS THE DEVICE WAS REC'D IN AN INOPERABLE CONDITION.