BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II

    MDR report key: 5841514 · Received August 2, 2016

    Report

    Report Number
    9610825-2016-00537
    Event Type
    Malfunction
    Date Received
    August 2, 2016
    Date of Event
    June 29, 2016
    Report Date
    July 6, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER) AND B. BRAUN MEDICAL INC. (THE IMPORTER). THE REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT# (B)(4). THE ACTUAL DEVICE HAS NOT BEEN RECEIVED AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. EVENT 3: B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN A SAMPLE. NO SAMPLE WAS RETURNED FOR EVALUATION ; BECAUSE OF THIS, FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE AND NO CONCLUSION COULD BE DRAWN. IF A SAMPLE AND/OR ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED. DEVICE HISTORY RECORD (DHR): REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO NON CONFORMANCES OR DEVIATIONS WERE NOTED IN PROCESS AND FINAL INSPECTION.

    Description of Event or Problem · 0

    AS REPORTED BY THE FACILITY: EVENT 3. THE CUSTOMER REPORTED SEVERAL INSTANCES WHERE THE PUMP HAS BEEN RETURNED BY THE NURSES WITH UNDELIVERED MEDICATION. THE REPORT THAT THEY ARE FILLING THEM WITH 240ML OF MEDS AND A SIGNIFICANT AMOUNT OF MEDICATION REMAINING (APPROX. 60 ML). NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492948 EASYPUMP II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG 15B03GE561

    Patients

    Seq Age Sex Outcome Treatment
    1