MEDFUSION 2001I SYRINGE INFUSION PUMP
Received Dec 1, 2006 · Event occurred Oct 29, 2006
Report 2183502-2006-00176 · MDR key 793719
Device
Generic name
Syringe Infusion Pump
Manufacturer
Smiths Medical MdModel number
2010ICatalog number
2010I
Lot number
NA
Product problems
- Excess Flow or Over-Infusion
- Repair
Patient
UNKNOWN
- Overmedicated
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE BIO-MED TECH AT THE USER FACILITY THAT HE 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
DEVICE EVAL: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. THE TAMPER STICKER WAS NOT INTACT, THE DEVICE HAD BEEN SERVICED IN THE FIELD, THERE WERE INDICATIONS THAT THE PUMP WAS NOT REASSEMBLED CORRECTLY. ADDITIONALLY, THERE WAS MUCH PHYSICAL DAMAGE TO THE DEVICE AND THE DEVICE WAS OUT OF CALIBRATION. AN ATTEMPT WAS MADE TO OPERATE THE PUMP TO TEST THE DELIVERY ACCURACY, A FLOW TEST WAS RUN 3 TIMES AND THERE WAS NO INDICATION OF AN OVER-DELIVERY.