BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5546097 · Received April 4, 2016

    Report

    Report Number
    9610825-2016-00176
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Report Date
    March 10, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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). WE RECEIVED ONE USED AND HALF FILLED EASYPUMP II LT 100-50-S WITHOUT PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL INSPECTION. THE WHITE CLAMP WAS CLOSED AND THE PATIENT CONNECTOR WAS NOT CLOSED, THE ORIGINAL WING CAP WAS NOT HANDED OVER FROM THE CUSTOMER. DAMAGES THAT WOULD LEAD TO A MALFUNCTION WERE NOT DETECTED AT THE SAMPLE. AFTER OPENING THE TOP CAP WE DETECTED SOLUTION AND CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE) AND AT THE PATIENT CONNECTOR (LLA-CONE) OF THE SAMPLE. THE SAMPLE WAS FILLED UP TO THE NOMINAL VALUE (100 ML) AND WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY LEAK TEST. AFTER STARTING THE PUMP AND WAITING FOR 60 MINUTES THE PUMP DID WORK (SOLUTION WAS RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED. THE INSPECTED SAMPLE IS WITHIN OUR SPECIFICATIONS. HENCE WE ASSESS THIS COMPLAINT TO BE NOT JUSTIFIED. REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN PROCESS AND FINAL CONTROL INSPECTION

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): NO DIFUSION. DRUG: 5FU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200734 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15C06GE26R

    Patients

    Seq Age Sex Outcome Treatment
    1