BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 5704223 · Received June 7, 2016

    Report

    Report Number
    9610825-2016-00341
    Event Type
    Malfunction
    Date Received
    June 7, 2016
    Date of Event
    May 9, 2016
    Report Date
    May 17, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 WAS IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT# (B)(4). THE ACTUAL DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. 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 PUMP WAS INITIALLY NOT RETURNED FOR EVALUATION BUT WAS RECEIVED AT A LATER DATE FOR SERVICE. THE CAPACITOR AND COVER CAPS WERE REPLACED AND PREVENTATIVE MAINTENANCE WAS PERFORMED. THE PUMP WAS THEN FUNCTIONALLY TESTED AND MET SPECIFICATIONS. THERMAL OR MECHANICAL OVERSTRESSING COULD GENERATE A DAMAGE OF THE CAPACITOR, E.G. CAUSED BY A DROP DOWN OF THE PUMP, CURRENT PEAKS OR A TOO HIGH AMBIENT TEMPERATURE. THE THERMAL DAMAGE IS LIMITED TO COMPONENT INSIDE THE HOUSING OF THE PUMP AND EXTINGUISHED BY ITSELF. TO AVOID RECURRENCE IN CASE OF MECHANICAL OR THERMAL OVERSTRESSING THE PHYSICAL SIZE OF THE CAPACITOR WAS CHANGED. THERE IS NO DANGER FOR THE PATIENT OR THE HEALTH PROFESSIONAL. THE THERMAL REACTION IS SELF-LIMITING AND HAPPENS ONLY IN THE INTERIOR OF THE PUMP HOUSING. ASSOCIATED DEVICES ARE NOT INVOLVED. PRECEDING EXTERNAL DAMAGE CANNOT BE EXCLUDED AS ROOT CAUSE FOR THE DESCRIBED EVENT.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: CUSTOMER REPORTED: THE PUMP WAS REMOVED FROM CHARGER AND WHEN TURNED ON SMELLED BURNING. THE PUMP WAS TURNED OFF. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358594 PERFUSOR SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1