BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5851908 · Received August 5, 2016

    Report

    Report Number
    9610825-2016-00540
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Date of Event
    July 7, 2016
    Report Date
    July 11, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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). WE RECEIVED ONE USED, COMPLETELY FILLED EASYPUMP II LT 100-50-S WITHOUT PACKAGING. THE PROVIDED PUMP WAS TAKEN TO A VISUAL INSPECTION. DAMAGES OR OTHER DEVIATIONS WERE NOT IMMEDIATELY DETECTED. IN AS-RECEIVED CONDITION THE CLAMP CLIP WAS CLOSED. THE ORIGINAL WING CAP WAS NOT HANDED OVER BY THE CUSTOMER, THE PATIENT CONNECTOR WAS BLOCKED BY A WHITE COMBI STOPPER. AFTER OPENING THE BIG WHITE TOP CAP AND REMOVING THE CLOSING CONE, WE DETECTED CRYSTALLIZED DRUG RESIDUES RESPECTIVELY SOLUTION (LIQUID) AT THE FILLING PORT (LLI-CONE). THE SAMPLE WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT (WITHOUT ADDING SOLUTION). AFTER STARTING THE PUMP (UNSCREWING THE CLOSING CONE AND OPENING THE CLAMP CLIP) AND WAITING FOR 60 MINUTES THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED. ALTHOUGH THE SAMPLE WAS NOT LEAKING WE DETECTED CRACKS IN THE LLI-CONE OF THE FILLING PORT. FURTHER ON, THE INSPECTED SAMPLE IS BLOCKED, THEREFORE IT IS NOT IN ACCORDANCE WITH OUR REQUIREMENTS. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE ACTUAL MANUFACTURER. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THEIR STATEMENT BECOMES AVAILABLE DEVICE HISTORY RECORDS (DHR):- REVIEWED DEVICE HISTORY RECORDS, THERE IS NO ABNORMALITIES AND NO SUCH DEFECT DETECTED 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 (B)(4) ): NO FLOW OF EASYPUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501269 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 14M06GE261

    Patients

    Seq Age Sex Outcome Treatment
    1