BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5435013 · Received February 12, 2016

    Report

    Report Number
    9610825-2016-00038
    Event Type
    Malfunction
    Date Received
    February 12, 2016
    Date of Event
    January 7, 2016
    Report Date
    January 20, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    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 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). STATEMENT FROM MANUFACTURER: WE ASSESS THIS COMPLAINT TO BE NOT "JUDGABLE". CORRECTIVE MEASURES REGARDING BLOCKAGE CAUSED BY GLUYING HAVE BEEN INITIATED AND ARE DOCUMENTED UNDER CAPA 001387. CORRECTIVE MEASURES REGARDING BLOCKAGE CAUSED BY OTHER DEFECTS THAN GLUYING HAVE BEEN INITIATED AND ARE DOCUMENTED UNDER CAPA 001475.

    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, APPROXIMATELY THREE QUARTERS FILLED EASYPUMP II LT 100-50-S WITHOUT PACKAGING. THE RECEIVED PUMP WAS TAKEN TO A VISUAL INSPECTION. IN AS-RECEIVED CONDITION THE WHITE CLAMP WAS CLOSED. THE ORIGINAL WING CAP WAS NOT HANDED OVER BY THE CUSTOMER; THE PATIENT CONNECTOR WAS CLOSED BY A BLUE STOPPER. AFTER OPENING THE TOP CAP WE DETECTED RESIDUES OF SOLUTION (LIQUID) AT THE FILLING PORT (LLI-CONE). IN ADDITION, WE DETECTED CRYSTALLIZED RESIDUES AT THE PATIENT CONNECTOR AND AT THE BLUE STOPPER. THE SAMPLE WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER STARTING THE PUMP (OPENING THE CLIP) AND WAITING FOR 60 MINUTES THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED. THE INSPECTED SAMPLE IS NOT IN ACCORDANCE WITH OUR REQUIREMENTS. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. 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)): NO INFUSION. DRUG: 5FU PFIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90927 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15B14GE26R

    Patients

    Seq Age Sex Outcome Treatment
    1