FDA Adverse Event Malfunction Summary report: N

INFUSOMAT®

MDR report key: 6563148 · Received May 12, 2017

Report

Report Number: 9610825-2017-00091
Event Type: Malfunction
Date Received: May 12, 2017
Report Date: April 17, 2017
Manufacturer: B. BRAUN MELSUNGEN AG
Product Code: FRN
UDI-DI: 04046964660887
PMA / PMN Number: K142596
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

EXEMPTION NUMBER E2016018 B. BRAUN INC. (BBMI) (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER(B)(4) FAILURE ANALYSIS AND INVESTIGATION RESULTS DID NOT CONFIRM THE REPORTED ISSUE. UPON RECEIPT THE ACTUAL PUMP INVOLVED WAS VISUALLY AND FUNCTIONALLY INSPECTED. THREE (3) VOLUMETRICS OF 677.5ML/HR AND 89.7ML TESTED IN SPEC. LOG REVIEW SUPPORTS THAT THE PUMP ALARMED AND PERFORMED AS DESIGNED AND INTENDED. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. THE PUMP OPERATED AS INTENDED AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. BASED ON THE RESULTS OF THE INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 0

AS REPORTED BY USER FACILITY: THE PUMP WAS PROGRAMMED TO RUN POTASSIUM 10 MEQ OVER AN HOUR PER PRE-SETTING ON THE PUMP BUT THE PUMP RAN THE POTASSIUM IN THE PATIENT IN 15 MINUTES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
345158	INFUSOMAT®	PUMP, INFUSION	FRN	B. BRAUN MELSUNGEN AG			04046964660887

Patients

Seq	Age	Sex	Outcome	Treatment
1