FDA Adverse Event Malfunction Summary report: N

PERFUSOR®

MDR report key: 8547364 · Received April 24, 2019

Report

Report Number: 9610825-2019-00126
Event Type: Malfunction
Date Received: April 24, 2019
Date of Event: March 28, 2019
Report Date: April 24, 2019
Manufacturer: B. BRAUN MELSUNGEN AG
Product Code: MEA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

EXEMPTION NUMBER E2016018 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE DEVICE HAS BEEN REQUESTED TO SEND IT FOR INVESTIGATION TO BBM LABORATORY IN MELSUNGEN, GERMANY. DURING THE ANALYSIS OF THE HISTORY LOG FILES IT COULD BE DETECTED THAT ON THE DAY OF OCCURRENCE THE DRIVE TEST ERROR "KPS OFF, CLAWS CLOSE" SEVERAL TIMES WERE OCCURRED. NO VISIBLE DAMAGES ON THE OUTSIDE COULD BE DETECTED. IT WAS IMPOSSIBLE TO BRING THE PUMP IN OPERATION, BECAUSE AFTER THE FINISHED SELF TEST THE DRIVE HEAD WAS MOVING OUT, BUT THE DRIVE BLOCKED IMMEDIATLY. NO SYRINGE COULD BE INSERTED IN THE PUMP. DURING AN INSIDE INVESTIGATION SOME DAMAGES OF THE DRIVE UNIT (GUIDE PARTS) AND THE MOTHERBOARD COULD BE DETECTED. THE DAMAGES PARTS OF THE GUIDE OF THE DRIVE UNIT ARE RESPONSIBLE FOR BLOCKING THE DRIVE. ALL DAMAGES COULD ONLY HAPPENED DUE EXTERNAL FORCES. THIS IS A HINT OF WRONG HANDLING BY THE CUSTOMER. THE COMPLAINT COULD NOT BE CONFIRMED.

Description of Event or Problem · 0

AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN UNITED KINDOM): "STOPPED MID INFUSION" CUSTOMER INFORMATION: PUMP STOPPED DURING AN INFUSION WITH A FROZEN SCREEN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
339173	PERFUSOR®	PUMP, INFUSION, PCA	MEA	B. BRAUN MELSUNGEN AG

Patients

Seq	Age	Sex	Outcome	Treatment
1