BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11129570 · Received January 7, 2021

    Report

    Report Number
    2016493-2021-02039
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Report Date
    January 13, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403222054
    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 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 REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE IS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    BD QUALITY ADVOCATE, THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. (B)(4). FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: BIOMED IS RUNNING ASM V9.4. USING KA 12043 ALARIS INFUSION ALARM BOLUS AIL LIMIT / FLOW BLOCK, WAS ABLE TO RESOLVE THE ISSUE AND SUCCESSFULLY TESTED THE UNIT. BIOMED ENDED CALL. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29294 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403222054

    Patients

    Seq Age Sex Outcome Treatment
    1