FDA Adverse Event Summary report: N

INFUSOMAT SPACE - US VERSION

MDR report key: 3722013 · Received February 26, 2014

Report

Report Number
2523676-2014-00029
Date Received
February 26, 2014
Report Date
February 20, 2014
Manufacturer
B. BRAUN MELSUNGEN AG.
Product Code
FRN
Product Problem
Yes
Report Source
Distributor report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

AS REPORTED BY THE USER FACILITY: THE NURSE PUT PU A 100 ML BAG AT 10 ML/H. AFTER APPROX. 6 HOURS, THE BAG AND TUBING WERE EMPTY UP TO THE PUMP, BUT THE REMAINING VOLUME INDICATED 45 ML REMAINING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
117505 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG. NA NA

Patients

Seq Age Sex Outcome Treatment
1 UNK