BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORIES FOR SPACE PUMPS

    MDR report key: 5775842 · Received July 7, 2016

    Report

    Report Number
    9610825-2016-00450
    Event Type
    Malfunction
    Date Received
    July 7, 2016
    Report Date
    June 21, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MRZ
    PMA / PMN Number
    K083689
    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). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). VISUAL INSPECTION RESULTS: THE SAMPLE SHOWS A LOT OF SIGNS OF USAGE AND WAS IN A BAD CONDITION. (FLUID RESIDUES) A THERMAL DAMAGE COULD BE FOUND AT THE UNION JOINT OF THE POWER SUPPLY. TRACES OF SOOT COULD BE FOUND ON THE CONNECTION BETWEEN THE POWER CORD AND THE POWER SUPPLY. YOU COULD ALSO SEE VERDIGRIS AT THE PLUG CONNECTION CAUSED BY AN ELECTROLYSIS UNLEASHED BY A FLUID INGRESS. THE CABLE OF THE P2 CONNECTOR WAS PULLED OUT. THE CONDUCTIVE PARTS OF THE C8 PLUG WERE MELTED DOWN. THE REST OF THE PLUG STUCK IN THE C7 CONNECTOR OF THE POWER SUPPLY. THE REASON FOR THE THERMAL DAMAGE IS A FLUID INGRESS BETWEEN THE CONNECTION OF THE C7 AND C8 PLUG. BASED ON THE THERMAL DAMAGE A FUNCTIONAL TEST COULD NOT BE PERFORMED. BASED ON PREVIOUS TEST IN THE PAST HAVE SHOWN THAT DAMAGES OF THIS NATURE ARE THE RESULTS OF FLUID INGRESS. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    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# (B)(4). THE ACTUAL DEVICE HAS NOT BEEN RECEIVED AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: THE CUSTOMER IS REPORTING THERMAL DAMAGE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429275 ACCESSORIES FOR SPACE PUMPS US POWER CORD INCL. EXTENSION MRZ B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1