FDA Adverse Event Malfunction Summary report: N

PERFUSOR SPACE

MDR report key: 2980109 · Received February 22, 2013

Report

Report Number: 9610825-2013-00028
Event Type: Malfunction
Date Received: February 22, 2013
Date of Event: February 4, 2013
Report Date: February 7, 2013
Manufacturer: B. BRAUN MELSUNGEN AG
Product Code: FPA
PMA / PMN Number: K062700
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN (B)(4) (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4). THE A REQUEST TO RETURN THE ACTUAL DEVICE INVOLVED IN THE EVENT HAS BEEN MADE TO THE REPORTING FACILITY. A F/U REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE.

Description of Event or Problem · 1

AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY (B)(4)): DELIVERY INACCURACY: A 50ML ANTIBIOTIC INFUSION INTENDED TO RUN OVER 30 MINUTES COMPLETED IN JUST OVER TWO MINUTES. THE PUMP EVENT LOG CONFIRMED CORRECT SETTING FOR INTENDED INFUSION, TOGETHER WITH DISPLAYED VOLUME INFUSED OF 4.18 ML (WHICH IS WHAT WOULD HAVE BEEN EXPECTED AFTER A RUN TIME OF A LITTLE OVER TWO MINUTES), YET IN EXCESS OF 40 ML HAVE BEEN INFUSED. USERS CONFIRMED THE STARTING VOLUME OF 50 ML, AND THAT THIS WAS CROSS CHECKED PRIOR TO COMMENCEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
77577	PERFUSOR SPACE	VOLUMETRIC PUMP	FPA	B. BRAUN MELSUNGEN AG	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other