BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8713050U

    MDR report key: 5837922 · Received August 1, 2016

    Report

    Report Number
    9610825-2016-00489
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Report Date
    July 20, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER) AND B. BRAUN MEDICAL INC. (THE IMPORTER). THE REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT# (B)(4). THE ACTUAL DEVICE HAS NOT BEEN RECEIVED AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). 3X AIR SENSOR TEST WITH 0.4ML AIR BUBBLE RESULTED IN 3 AIR ALARMS. WITH 2ML PRIME AND SUBSEQUENT INFUSION START FUNCTIONING CORRECTLY. AIR SENSOR WITH FLUID IN LINE READ 1008MV; ACCEPTABLE RANGE IS >600MV. AIR SENSOR WITH AIR IN LINE READ 44MV; ACCEPTABLE RANGE IS <100MV. INCOMING PUMP AIR BUBBLE SET TO 0.3ML; AIR VOLUME/HR SET TO 3.8ML/HR. THE TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PUMP'S OPERATIONAL LOG WAS REVIEWED AND THERE WERE NO INDICATION THAT THE PUMP MALFUNCTIONED. BASED ON THE RESULTS OF THE INVESTIGATION, THE PUMP OPERATED AS INTENDED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE FACILITY: THE CUSTOMER REPORTED THAT THE "AIR IN LINE" CAUSED THE PATIENT'S BLOOD PRESSURE TO FLUCTUATE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489010 8713050U INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1