BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11099032 · Received December 30, 2020

    Report

    Report Number
    2016493-2020-75523
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Report Date
    December 16, 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

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. 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 NOT RETURNED FOR SERVICING WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A TRACKWISE 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.

    Description of Event or Problem · 1

    (B)(4). FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: USE KA 12043 ALARIS INFUSION ALARM BOLUS AIL LIMIT / FLOW BLOCK WHICH CORRECT THE ISSUE. BIOMED ENDED CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557733 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1