BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 5786771 · Received July 12, 2016

    Report

    Report Number
    9610825-2016-00472
    Event Type
    Malfunction
    Date Received
    July 12, 2016
    Date of Event
    June 11, 2016
    Report Date
    June 16, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 INC. 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 INSPECTION 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). THE VOLUMETRIC ACCURACY WAS TESTED THREE TIMES AT 25ML/HR AND 8ML AND THE PUMP TESTED IN SPECIFICATIONS. BASED ON THE EVALUATION RESULTS, THERE WERE NO INDICATION THAT THE PUMP MALFUNCTIONED. THE PUMP OPERATED AS INTENDED AND THE REPORTED DEFECT WAS NOT CONFIRMED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: EVENT: UNDER INFUSION: EVENT DESCRIPTION: THE CUSTOMER RECENTLY BEGAN USING PERFUSOR SPACE WITH THE 10 ML BD SYRINGES FOR ANTIBIOTICS AND DISCOVERED APPROX .5 MLS LEFT IN THE SYRINGE FROM A 6-8 ML INFUSION. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438727 PERFUSOR SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1