BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 20532177 · Received October 25, 2024

    Report

    Report Number
    2016493-2024-39760
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    October 2, 2024
    Report Date
    February 4, 2025
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403519284
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 COMMUNICATION FAILURE WAS CONFIRMED DURING ASM TESTING. CONTAMINATION WAS FOUND ON CONNECTOR PINS OF THE SIO BOARD, CAUSING THE COMMUNICATION FAILURE. ON 08-NOV-2024 PCU DEVICE WAS RECEIVED UNBOXED AND WITH PAPERWORK. EXTERNAL INVESTIGATION REVEALED NO PHYSICAL DAMAGE, COSMETIC DAMAGE OR LABELLING DAMAGE. INTERNAL INVESTIGATION REVEALED CONTAMINATED PINS ON THE SIO BOARD CAUSING THE COMMUNICATION FAILURES. DEVICE TO BE RETURNED TO SAN DIEGO REPAIR CENTER FOR PROCESSING. RECOMMEND BD SAN DIEGO REPAIR CENTER TO REPLACE THE SIO BOARD. FAILURE INVESTIGATION REPORT ATTACHED TO QN IN SAP. 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. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD COMMUNICATION FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795635 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403519284

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown