BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5448482 · Received February 19, 2016

    Report

    Report Number
    9610825-2016-00066
    Event Type
    Malfunction
    Date Received
    February 19, 2016
    Report Date
    February 2, 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). THE DEVICE IS CURRENTLY SHIPPING FROM (B)(6) TO BBM IN (B)(4) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE. REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN-PROCESS AND FINAL CONTROL INSPECTION.

    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 AT THE FILLING PORT (LLI-CONE) OF THE SAMPLE. FURTHERMORE WE DETECTED CRYSTALLIZED DRUG RESIDUES OUTSIDE OF THE SAMPLE AND AT THE PATIENT CONNECTOR (LLA-CONE). IN ADDITION 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. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. DEFINE: RECEIVED ONE PIECE OF USED, FILLED OF EASYPUMP II LT 100-50-S WITHOUT ORIGINAL PACKAGING. AS RECEIVED CONDITION, CLAMP CLIP WAS CLAMPED AND THE ORIGINAL WING CAP WAS NOT OBSERVED AT THE PUMP. BIG TOP CAP WAS OPENED. OBSERVED SOLUTION RESIDUE AT FILLING PORT. ADDITIONALLY, DETECTED CRYSTALLIZED RESIDUE OUTSIDE THE SAMPLE AND AT MALE LUER LOCK. COMPLAINT SAMPLE WAS FILLED UP UNTIL THE NOMINAL VOLUME (100 ML) AND TAKEN FOR FUNCTIONAL TEST, RESPECTIVELY LEAK TEST. AFTER 60 MINUTES, THE PUMP WAS WORKING. NO OTHER DEVIATION WAS OBSERVED. CONCLUSION: BLOCKAGE DEFECT AS MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. THEREFORE, THE COMPLAINT IS CLASSIFIED AS NOT JUDGEABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (B)(4):STOP OF INFUSION.DRUG: 5FU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103612 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15A13GE261

    Patients

    Seq Age Sex Outcome Treatment
    1