BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 6041913 · Received October 19, 2016

    Report

    Report Number
    9610825-2016-00667
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 27, 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 AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). DEVICE HISTORY RECORDS (DHR): REVIEWED DEVICE HISTORY RECORDS, THERE IS NO ABNORMALITIES AND NO SUCH NON CONFORMANCE DETECTED AT FINAL CONTROL INSPECTION. SAMPLE EVALUATION: RECEIVED ONE AND FILLED WITH BROWNISH SOLUTION EASYPUMP II LT 270-27-S (BATCH NO. LABELED 16E19GE221 /MATERIAL NO. 4540008 ON THE BIG BOTTOM CAP OF THE SAMPLE) WITHOUT ORIGINAL PACKAGING. EXAMINED THE RETURNED SAMPLE VISUALLY. CLAMP CLIP WAS CLAMPED. PATIENT CONNECTOR (DISTAL END) WAS NOT CLOSED WITH THE ORIGINAL CLOSING CONE (DISTAL END CAP). FILLING CAP (DISCOFIX) WAS ATTACHED WITH FILLING PORT. ACCORDING TO TEST SPECIFICATION SOP HC-MY01-M-5-4-10-601-0-N, TEST METHOD (B)(4), DAMAGES AND CRACKS AND LEAKAGES WERE NOT DETECTED UPON VISUAL INSPECTION. SAMPLE WAS FILLED WITH BLUE DYED SOLUTION TO NOMINAL VOLUME 270ML. THE COMPLAINT SAMPLE WAS UNCLAMPED TO PRIME THE TUBING AND OBSERVED THE PUMP IS WORKING AFTER 30 MINUTES (SOLUTION WAS RUNNING). THE INSPECTED SAMPLE IS WITHIN OUR SPECIFICATIONS.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): BLOCKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692055 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 16E19GE221

    Patients

    Seq Age Sex Outcome Treatment
    1