BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II

    MDR report key: 4360514 · Received December 17, 2014

    Report

    Report Number
    9610825-2014-00456
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Report Date
    November 28, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE RECEIVED ONE USED FILLED EASY PUMP II LT 100-50-S WITHOUT PACKAGING. WE DETECTED A CRACK AT THE FILLING PORT (LLI-CONE). IN AS-RECEIVED CONDITION THE WHITE CLAMP WAS CLOSED. THE ORIGINAL WING CAP WAS NOT RETURNED BY THE CUSTOMER. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED SOLUTION (LIQUID) AND CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE). FURTHERMORE WE DETECTED NO CRYSTALLIZED DRUG RESIDUES AT THE LLA-CONE OF THE PT CONNECTOR. ADDITIONALLY THE PUMP WAS FILLED WITH NACL 0.9% UP TO THE NOMINAL VALUE (100 ML) AND A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER FILLING THE PUMP AND WAITING FOR A WHILE THE PUMP WORKED (SOLUTION WAS RUNNING). LEAKAGES WERE NOT DETECTED AT THE SAMPLE. FURTHERMORE WE TESTED THE FLOW RATE OF THE RECEIVED SAMPLE. NOMINAL: 2 ML/H ACTUAL: 1, 9 ML IN 1 H; 3, 8 ML IN 2 HRS; 6, 4 ML IN 3 HRS. THE FLOW OF THE RECEIVED SAMPLE IS WITHIN OUR SPECIFICATIONS. DURING THE TEST OF THE FLOW RATE WE DETECTED NO LEAKS AT THE SAMPLE. WE HAVE INFORMED OUR MFR ACCORDINGLY. THE COMPLAINT WAS NOT JUSTIFIED AS THE SAMPLES WERE WITHIN SPECIFICATION. REVIEWED THE DEVICE HISTORY RECORD AND THERE WERE NO DEFECTS ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INVESTIGATIONS.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFO BY (B)(4)): UNABLE TO START THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830160 EASYPUMP II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG NA 14G08GE262

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK