BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BASIC

    MDR report key: 5594101 · Received April 21, 2016

    Report

    Report Number
    9610825-2016-00219
    Event Type
    Malfunction
    Date Received
    April 21, 2016
    Report Date
    April 4, 2016
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K003029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH 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 MEDICAL INTERNAL REPORT (B)(4). MULTIPLE ATTEMPTS TO OBTAIN THE DEVICE AND ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. WITHOUT THE ACTUAL DEVICE AND/OR LOGS, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED AND FURTHER EVALUATION WAS NOT POSSSIBLE. IF THE DEVICE AND/OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    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 MEDICAL INTERNAL REPORT (B)(4). THE DEVICE HAS NOT BEEN RECEIVED YET AND THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE PROVIDED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: CUSTOMER CALLED BECAUSE SHE IS IN A PATIENT'S HOME GIVING AN INFUSION AND THE PUMP CONTINUES TO ALARM "PUMP STOPPED PRESS START." THE CUSTOMER STATES THAT THE INFUSION DOES NOT STOP WHEN THIS ALARM APPEARS AND THE PUMP APPEARS TO BE INFUSING CORRECTLY BASED ON THE INFORMATION PROGRAMMED INTO THE PUMP. THE VOLUME TO BE DISPENSED ALONG WITH THE TIME CONTINUE TO COUNT DOWN CORRECTLY AND THE BARS ON THE BOTTOM OF THE PUMP ARE PRESENT.... THE PUMP ALARMS "PUMP STOPPED PRESS START" AND WHEN SHE PRESSES START THE PUMP CONTINUES TO INFUSE CORRECTLY. SERIAL-UNKNOWN AT THIS TIME. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249285 VISTA BASIC INFUSION PUMP FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1