BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MSIII 5.0 DLE INF PMP

    MDR report key: 10611907 · Received October 1, 2020

    Report

    Report Number
    2016493-2020-16136
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Report Date
    February 5, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403928659
    PMA / PMN Number
    K933545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICE. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE AND PRODUCT WAS NOT RETURNED FOR THE SERVICING WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED THAT THIS DEVICE WAS INVOLVED IN A SERVICING FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. THE TW COMPLAINT HISTORY REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT MULTIPLE COMPLAINTS WERE RECEIVED WITH SIMILAR SN (B)(4). WE WILL CONTINUE TO MONITOR ALL COMPLAINTS AND FAILURE MODES FOR UPWARD TRENDING AND TAKE APPROPRIATE ACTION AS REQUIRED. CAPA REFERENCE: (B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). (B)(6) HAD A MSIII INFUSION PUMP FAILED FSOD CALIBRATION STEP 1 (IT WOULD NOT RUN). I REVIEW CALIBRATION PROCESS WITH (B)(6) AND ADVISED HIM TO REPLACE MEA BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082482 MSIII 5.0 DLE INF PMP PUMP, INFUSION FRN CAREFUSION SD 2865 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1