BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 7377257 · Received March 28, 2018

    Report

    Report Number
    9610825-2018-00049
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    February 20, 2018
    Report Date
    March 28, 2018
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    UDI-DI
    04046964448638
    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 E2016018 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, EMPTY EASYPUMP II LT 270-54-S WITHOUT PACKAGING. THE PROVIDED SAMPLE WAS SUBJECTED TO A VISUAL INSPECTION. WE DETECTED A CRACK IN THE LLI-CONE OF THE FILLING PORT AT THE SAMPLE. AFTER OPENING THE BIG WHITE TOP CAP WE DETECTED SOLUTION AT THE FILLING PORT (LLI-CONE). WE DETECTED NO SOLUTION (LIQUID) AND NO RESIDUES OF MEDICINE DRUG AT THE PATIENT CONNECTOR. ADDITIONALLY THE PUMP WAS FILLED WITH NACL 0.9 % UP TO THE NOMINAL VALUE (270 ML) AND A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER OPENING THE CLAMP CLIP AND STARTING THE PUMP AND WAITING FOR 60 MINUTES THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED AT THE SAMPLE. BECAUSE THE SAMPLE IS BLOCKED A TOO FAST FLOW (AS DESCRIBED BY THE CUSTOMER) COULD NOT BE DETERMINED AT THE SAMPLE. DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR AND NO ABNORMALITY OBSERVED FOR THIS DEFECT DURING IN-PROCESS AND AT 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 FRANCE): PUMP-FLOW RATE-FAST

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220359 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 16K01GE271 04046964448638

    Patients

    Seq Age Sex Outcome Treatment
    1