BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 21341634 · Received February 10, 2025

    Report

    Report Number
    2016493-2025-61658
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    July 1, 2024
    Report Date
    January 30, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403516023
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING. INVESTIGATION SUMMARY: FIELD TECHNICIAN STATED ISSUE OF FAILED IUI CONNECTORS TEST WAS CONFIRMED. ON 7-NOV-24, PCU WAS RECEIVED UNBOXED AND WITH PAPERWORK. CONFIRMED RIGHT & LEFT IUI¿S DO NOT POWER LVP¿S ON. BAD U22 ON THE PCU LOGIC BOARD HAS FAILED AND MODULES CANNOT GET POWER. DEFECTIVE MATERIAL FROM SUPPLIER. DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR PROCESSING. RECOMMEND BD SAN DIEGO REPAIR CENTER REPLACE FAILED PCU LOGIC BOARD. FAILURE INVESTIGATION REPORT ATTACHED TO QN IN SAP. 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 HAD FAILED IUI CONNECTORS TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836658 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403516023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown