BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 5233619 · Received November 18, 2015

    Report

    Report Number
    2016493-2015-00756
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    October 21, 2015
    Report Date
    June 6, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY CUSTOMER'S MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE OF SMOKE APPEARING FROM THE PCU AND PUMP MODULE WAS CONFIRMED. THE RIGHT IUI CONNECTOR WAS OBSERVED TO BE THERMALLY DAMAGED AND FOUND TO BE IN A SHORTED STATE AT PINS 13 AND 14. THE PCU WAS ALSO NOTED TO HAVE DRIED FLUID RESIDUE ON THE BODY OF THE RIGHT IUI CONNECTOR, AND THE CONNECTOR HAD A CRACK IN IT WITHIN THE WELL FEATURE THAT RAN ABOVE PINS 12 THROUGH 15. THE LEFT IUI CONNECTOR ON THE PUMP MODULE WAS THERMALLY DAMAGED AND IS CONSIDERED COLLATERAL DAMAGE DUE TO ITS CONNECTION TO THE SOURCE PCU. BOTH THERMALLY DAMAGED IUI CONNECTORS WERE OVER 8 YEARS OLD. THE PROXIMATE CAUSE FOR THE REPORTED ISSUE OF SMOKE OBSERVED FROM THE PC AND PUMP MODULE IS ATTRIBUTED TO THE THERMALLY DAMAGED RIGHT IUI CONNECTOR ON THE PCU. THE ROOT CAUSE FOR THE OCCURRENCE OF THE THERMAL EVENT AT THE RIGHT IUI CONNECTOR ON THE PCU IS NOT KNOWN, HOWEVER IT IS SUSPECTED THAT THE MOST LIKELY CAUSE IS THE CRACK IN THE CONNECTOR, WHICH MAY HAVE ALLOWED FLUID INGRESS INTO THE CONNECTOR AT SOME POINT AS SUGGESTED BY THE DRIED FLUID RESIDUE.

    Description of Event or Problem · 1

    RECEIVED A COPY OF CUSTOMER'S MEDWATCH REPORT WHICH STATES "EVENT DESC: IV WAS BEEPING. RN PLUGGED MACHINE BACK INTO THE WALL OUTLET, RESTARTED THE PUMP, AND SMOKE AROSE BETWEEN THE MAIN 'BRAIN' OF THE PUMP AND THE ADDITIONAL CHANNEL."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE HAS "A PC AND PUMP MODULE THAT SMOKED." THERE IS NO REPORT OF A PATIENT EVENT. VIRTUALLY NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764224 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other 8100, THERAPY DATE UNK