FDA Adverse Event Malfunction Summary report: N

INFUSOMAT SPACE

MDR report key: 2462019 · Received February 10, 2012

Report

Report Number: 9610825-2012-00007
Event Type: Malfunction
Date Received: February 10, 2012
Report Date: February 10, 2012
Manufacturer: B. BRAUN MELSUNGEN AG
Product Code: FRN
PMA / PMN Number: K062700
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FI
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

EXEMPTION NUMBER (B)(4). B BRAUN MEDICAL, INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B BRAUN (B)(4) (MFR). THIS REPORT HAS BEEN IDENTIFIED AS B BRAUN (B)(4). THE HISTORY LOG FILES OF THE RECEIVED SAMPLE WERE READ AND ANALYZED. THE THERAPY INDICATED BY THE CUSTOMER COULD NOT BE FOUND ON THE ANNOUNCED DAY. A 24 HOUR LONG TERM TEST WAS REQUESTED TO DETERMINE THE THERAPY. NO FREE FLOW OCCURRED. THE DEVICE WAS TESTED ACCORDING TO THE REQUIREMENTS OF THE TECHNICAL SAFETY CHECK IN TRIPLICATE. ALL MEASURED VALUES WERE WITHIN SPEC. THE RETURNED INFUSOMAT SPACE PUMP MEET THE REQUIREMENTS. NO SPECIFIC CONCLUSION CAN BE DRAWN.

Description of Event or Problem · 1

AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY (B)(4)): TOO MANY DROPS. INFUSOMAT SPACE GAVE ALARM "TOO MANY DROPS" OVER AND OVER AGAIN EVEN PUMP WAS STOPPED BY PRESSING START/STOP BUTTON. THE STAFF NOTICED FREE FLOW-CASE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFUSOMAT SPACE	INFUSION PUMP	FRN	B. BRAUN MELSUNGEN AG	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other