BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 21763284 · Received April 3, 2025

    Report

    Report Number
    2016493-2025-70684
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 14, 2025
    Report Date
    May 15, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403519284
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. 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.

    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. FIELD TECHNICIAN STATED ISSUE OF LEFT IUI COMMUNICATION FAILURE WAS CONFIRMED. RECEIVED ON 12-MAY-2025, PVU DEVICE WAS RECEIVED UNBOXED AND WITH PAPERWORK. PCU UNIT WAS NOT ABLE TO DETECT THE TEST LVP MODULE THAT WAS CONNECTED ON ITS LEFT IUI CHANNEL. UNIT ALSO FAILED THE IUI CONNECTOR TEST ON ASM. DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR NORMAL PROCESSING. RECOMMENDED BD SAN DIEGO REPAIR CENTER TO REPLACE FAULTY LEFT IUI CONNECTOR AND DAMAGED FRONT CASE. FAILURE INVESTIGATION REPORT ATTACHED TO SALESFORCE. THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING. 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 COMMUNICATION FAILURE IN IUI FEMALE (LEFT). THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD COMMUNICATION FAILURE IN IUI FEMALE (LEFT). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847041 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403519284

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown