FDA Adverse Event Malfunction Summary report: N

GEMINI PC-1

MDR report key: 861651 · Received June 5, 2007

Report

Report Number: 2016493-2007-00020
Event Type: Malfunction
Date Received: June 5, 2007
Date of Event: March 30, 2007
Report Date: April 23, 2007
Manufacturer: CARDINAL HEALTH ALARIS PRODUCTS
Product Code: FRN
PMA / PMN Number: K012383
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

Description of Event or Problem · 1

OVERINFUSION OF CARDIZEM. INFUSION OF CARDIZEM 125 MG IN 100 ML PROGRAMMED TO INFUSE AT 5 ML/HR. INFUSION COMPLETE IN 2:20HR. PUMP DISPLAY SHOWED 90ML VTBI WHEN CONTAINER EMPTY. DEVICE RETURNED TO CLINICAL ENG WHO EVALUATED DEVICE AND REPORTED THE PUMPING MECHANISM WAS NOT SECURED TO THE PUMP AND ALLOWED THE PUMP TO INFUSE IN AN UNREGULATED FLOW. THE DEVICE WAS REPAIRED BY THE FACILITY AND NOT AVAILABLE TO RETURN TO US FOR EVALUATION. REQUESTED THE DEVICE, HOWEVER, THE FACILITY DID NOT AGREE TO RETURN, STATING THEY HAD DONE THE REPAIR. THE DEVICE WAS NEVER RETURNED TO THE MFR FOR ANY WARRANTY OR SERVICE REPAIRS. THE FACILITY CONFIRMED THEY HAD RECENTLY, IN 2007, PERFORMED SERVICE ON THE DEVICE, BUT COULD NOT CONFIRM IF ANY SERVICE WAS PERFORMED SPECIFICALLY ON THE PUMPING MECHANISM. THERE HAS NOT BEEN ANY CORRECTIVE ACTIONS MADE TO THE INSTALLATION OF THIS PUMP MECHANISM. ALTHOUGH WE DID NOT RECEIVE THE DEVICE AND CAN NOT CONFIRM THE MALFUNCTION, AND THERE WAS NO PT INJURY OR HARM, WE ARE REPORTING THIS EVENT AS A MALFUNCTION BASED ON ADDITIONAL INFORMATION RECEIVED BY THE CUSTOMER ON THEIR EVALUATION AND REPAIR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GEMINI PC-1	FRN, INFUSION PUMP	FRN	CARDINAL HEALTH ALARIS PRODUCTS	1310BR	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR