BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 21949716 · Received May 2, 2025

    Report

    Report Number
    2016493-2025-77643
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    April 7, 2025
    Report Date
    May 13, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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. INVESTIGATION SUMMARY: FIELD TECHNICIAN STATED ISSUE OF ERROR CODE 13-1064-1229 WAS CONFIRMED. ¿ ON 24-APR-2025, LVP DEVICE WAS RECEIVED UNBOXED AND WITH PAPERWORK. ¿ ERROR CODE 13-1064-1229 APPEARED AT POWER UP. A MISSING SERIAL NUMBER ON ASM WAS OBSERVED CAUSING THE ERROR CODE 13-1064-1229 TO APPEAR. ¿ DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR NORMAL PROCESSING. ¿ NOTED ISSUE(S) WERE CORRECTED IN BD SAN DIEGO OPERATION¿S LAB. NO REPAIR REQUIRED BY BD SAN DIEGO REPAIR CENTER. ¿ FAILURE INVESTIGATION REPORT ATTACHED TO SALESFORCE. 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 13-1064-1229. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE 13-1064-1229. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208109 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown