BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5427980 · Received February 10, 2016

    Report

    Report Number
    9610825-2016-00031
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    January 15, 2016
    Report Date
    January 18, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 A(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). DEFINE: RECEIVED ONE PIECE OF USED, FILLED OF EASYPUMP II LT 270-27-S WITHOUT ORIGINAL PACKAGING. AS RECEIVED CONDITION, CLAMP CLIP WAS CLOSED AND THE ORIGINAL WING CAP WAS STILL ATTACHED TO THE PUMP. BIG TOP CAP WAS OPENED AND DISCOFIX CAP WAS REMOVED. NO SOLUTION/CRYSTALLIZED RESIDUE WAS OBSERVED AT THE FILLING PORT. WHEN WING CAP WAS REMOVED AND CLAMP CLIP WAS RELEASED, IMMEDIATELY OBSERVED FLOW AT THE PUMP. THE COMPLAINT SAMPLE WAS WORKING. NO OTHER DEVIATION WAS OBSERVED AT THE PUMP. CONCLUSION: BLOCKAGE DEFECT AS MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. THEREFORE, THE COMPLAINT IS CLASSIFIED AS NOT "JUDGABLE". JUSTIFICATION: NOT "JUDGABLE".

    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). RECEIVED ONE USED EASYPUMP II LT 270-27-S, WITHOUT PACKAGING. SAMPLE WAS TAKEN TO A VISUAL INSPECTION. NO DAMAGES WERE DETECTED. IT WAS INDICATED BY CUSTOMER THAT PUMP WAS INFUSED WITH DRUG VANCOMYCIN - AND NOT FLOWING (BLOCKAGE). COMPLAINT SENT TO PRODUCTION FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE STATEMENT IS AVAILABLE. 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)): DRUG (VANCOMYCIN) CANNOT FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84215 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15B20GE221

    Patients

    Seq Age Sex Outcome Treatment
    1