BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II

    MDR report key: 3854193 · Received May 29, 2014

    Report

    Report Number
    9610825-2014-00214
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE RECEIVED 2 USED EASYPUMP II ST 100-0,5-S WITHOUT PACKAGE AND 1 SAMPLE IN ORIGINAL PACKAGE. THE RECEIVED SAMPLES WERE TAKEN TO A VISUAL EXAMINATION. DAMAGES OR MANUFACTURING FAULTS WERE NOT DETECTED. IN AS-RECEIVED CONDITION, 1 USED SAMPLE WAS EMPTY AND 1 USED SAMPLE WAS HALF FILLED WITH SOLUTION. THE WHITE CLAMPS WERE CLOSED AT BOTH SAMPLES. THE ORIGINAL WING CAP WAS NOT ASSIGNED BY THE CUSTOMER. AFTER OPENING THE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE FILING PORT (LLI-CONE) AT 1 USED SAMPLE. RESIDUES OF FLUID OR CRYSTALLIZED DRUG RESIDUES AT THE LLA-CONE OF THE PATIENT CONNECTORS WERE NOT DETECTED. ADDITIONALLY THE PUMPS WERE FILLED WITH NACI 0.9% UP TO THE NOMINAL VALUE (100ML) AND A FUNCTIONAL TEST, RESPECTIVELY A LEAK TEST, WAS CARRIED OUT. AFTER FILLING THE PUMPS, OPENING THE WHITE CLAMP AND WAITING FOR A WHILE THE PUMPS WORK (SOLUTION WAS RUNNING). LEAKAGES WERE NOT DETECTED ON BOTH SAMPLES. FURTHERMORE WE TESTED THE FLOW RATE OF THE RECEIVED SAMPLES. NOMINAL: 100 ML/1/2 H. ACTUAL (2 USED SAMPLES): 97.6 ML AND 95.8 ML IN 1/2 H. ACTUAL (ORIGINAL PACKED SAMPLE): 97.5 ML. AFTER THIS TEST OF FLOW RATE ALL SAMPLES ARE EMPTY. WE ASSESS THIS COMPLAINT TO BE NOT JUSTIFIED. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316831 EASYPUMP II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1