BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 PUMP MODULE V9.33.0

    MDR report key: 10963823 · Received December 7, 2020

    Report

    Report Number
    2016493-2020-60154
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Report Date
    February 12, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    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. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A TRACK WISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). CUSTOMER CALLED IN FOR HELP ON 8100 UNIT KEEPS GET PATIENT SIDE OCCULSION TESTER FAIL. CUSTOMER CAWS RUNNING THE PM TEST AND UNIT TIME OUT WITH ERROR WHILE ON THE PHONE WITH CUSTOMER HE NOTICE THE BEZEL ASSY. THE HINGE IS CRACK NEEDS TO BE REPLACE THAT MAY BE HIS ISSUE. CUSTOMER WILL REPLACE BEZEL AND CALL BACK IF THAT DOES NOT RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428759 8100 PUMP MODULE V9.33.0 PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other