BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11278964 · Received February 4, 2021

    Report

    Report Number
    2016493-2021-16347
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Report Date
    May 22, 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¿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 RETURNED FOR SERVICING WHICH 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. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). CASE DESCRIPTION: CALLER HAS AN 8100 MODULE GIVING A 242.4030. SN: (B)(4). CASE RESOLUTION: USED KA 12066 ALARIS INFUSION ERROR 242.4030. MOTOR MOVEMENT SEEN. RECOMMENDED TO REPLACE AIL SENSOR. BIOMED WILL CONDUCT REPAIR AND CALL BACK IF FURTHER ASSISTANCE IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173951 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403222054

    Patients

    Seq Age Sex Outcome Treatment
    1