BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11144369 · Received January 10, 2021

    Report

    Report Number
    2016493-2021-02892
    Event Type
    Malfunction
    Date Received
    January 10, 2021
    Report Date
    January 22, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. A DHR (DEVICE HISTORY RECORD) REVIEW CANNOT BE COMPLETED AS THE SERIAL NUMBER WAS NOT OBTAINED UPON RECEIPT OF THE COMPLAINT. ADDITIONALLY, A HISTORICAL REVIEW OF COMPLAINTS IN TRACKWISE CANNOT BE CONDUCTED. THE CUSTOMER STATED THAT THERE IS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CASE #: 00968577 CASE SUBJECT: NPI PATIENT SIDE OCCLUSION TEST FAIL ACCOUNT NAME: TENNESSEE VALLEY VETERANS AFFAIRS HEALTHCARE SYSTEM 626A4 ACCOUNT #: 3894778 ASSET NAME: 8015LS PCU DOM V9.33.1.2 A/B/G/N ASSET LOCATION: CONTACT: KEITH TODD CONTACT EMAIL: [email protected] CONTACT PHONE: 615-895-1103 CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: TECH CALLED FOR HELP ON SERVERAL 8100 UNITS FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: TECH CALLED IN THEY HAVE 139 8100 UNITS AND THEY DOING THIER YEARLY PM TEST AND 10 OF THE 8100 UNITS ALL FAIL ON THE PATIENT SIDE OCCLUSION TEST FAIL DOING PM TEST HE HAD ALSO RAN CALIBRATION TEST ALSO ON UNIT ALL FAIL PRESSURE TEST. TECH NEED TO REPLACE PRESSURE SENSOR WHICH IS THE BOTTOM SENSOR BUT THEY CAN REPLACE BOTH WANT HURT BUT UP TO YOU GUYS, ALSO ONE 8100 UNIT THE DISPLAY BOARD IS OUT AND NEED TO BE REPLACE, CONFIRM BOTH PART NUMBERS FOR PRESSURE SENSOR & DISPLAY BOARD, TRANSFER TECH TO ORDER MGR. DEPT. TO GET PRICE QUOTE WITH TAX. TECH THANK ME FOR MY ASSIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41076 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1