BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10715106 · Received October 21, 2020

    Report

    Report Number
    2016493-2020-25437
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Report Date
    October 9, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOR (B)(6) WAS PERFORMED FROM DATE OF MANUFACTURE 07/02/2004 TO THE PRESENT DATE 10/20/2020 AND CONFIRMED THAT THIS DEVICE WAS PREVIOUSLY RETURNED FOR SERVICING UNRELATED TO THE CUSTOMER REPORTED ISSUE. THERE WERE NO PRODUCTION FAILURES WHICH CORRELATE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE RECEIVED THE ERROR CODE 210.5020. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM DATE OF MANUFACTURE 07/02/2004 TO THE PRESENT DATE 10/20/2020 AND CONFIRMED THAT THIS DEVICE WAS PREVIOUSLY RETURNED FOR SERVICING UNRELATED TO THE CUSTOMER REPORTED ISSUE. THERE WERE NO PRODUCTION FAILURES WHICH CORRELATE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RECEIVED THE ERROR CODE 210.5020. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175625 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown