BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 24269896 · Received February 5, 2026

    Report

    Report Number
    2016493-2026-04629
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 15, 2026
    Report Date
    February 23, 2026
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. - RECEIVED ON 02-FEB-2026, LVP DEVICE WAS RECEIVED UNBOXED AND WITH PAPERWORK. - ERROR CODE 13-1064-1229 APPEARED AT POWER UP. CHANNEL ERROR 13-1064-1229 DUE TO NO SERIAL NUMBER INSTALLED. - FAULTY LOGIC BOARD. DEFECTIVE MATERIAL FROM SUPPLIER. - DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR PROCESSING. - RECOMMENDED BD SAN DIEGO REPAIR CENTER TO REPLACE THE LOGIC BOARD. - 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.

    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
    333759 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown