BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 19630934 · Received June 28, 2024

    Report

    Report Number
    2016493-2024-30596
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    May 29, 2024
    Report Date
    July 10, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801549
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-1520-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ANNEX B: B21, ANNEX C: C21, ANNEX D: D16. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER?, REMEDIAL ACTION REQUIRED, REMEDIAL ACTION #, ANNEX A: A070504, ANNEX B: B01, ANNEX C: C0501, ANNEX D: D09, ANNEX G: G02002.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN THIS MDR REPORT. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2175056 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801549

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown