BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10865204 · Received November 18, 2020

    Report

    Report Number
    2016493-2020-43648
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Report Date
    October 15, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM DATE OF MANUFACTURE 7/25/2006 TO THE PRESENT DATE 11/18/2020 AND NOTE THAT THIS DEVICE HAS BEEN RETURNED FOR SERVICE TWO TIMES WITHOUT CORRELATION TO THE CUSTOMER REPORTED ISSUE OR SERVICE REPAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ATL ERROR ON THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329163 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1