BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM

    MDR report key: 15174033 · Received August 5, 2022

    Report

    Report Number
    2016493-2022-173887
    Event Type
    Injury
    Date Received
    August 5, 2022
    Date of Event
    July 15, 2022
    Report Date
    August 13, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. 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 REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 0

    CORRECTION: IT WAS DETERMINED THROUGH INVESTIGATION OF THE RETURNED DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE REPORTED UNDER MANUFACTURER REPORT NUMBER 2016493-2022-173887 IS A CONCOMITANT. PLEASE REFER TO MANUFACTURER REPORT NUMBER 2016493-2022-173989, WHICH CAPTURED THE CORRECT SUSPECT DEVICE PER INVESTIGATION REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP SCREEN SHUT OFF DURING INFUSION. THE CUSTOMER ADDITIONALLY INDICATED "POTENTIAL OVER-INFUSION" ALTHOUGH REQUESTED, NO ADDITIONAL DETAILS WERE PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PCU AND PUMP MODULE DISPLAY SHUT OFF DURING INFUSION. THE PUMP WAS SET UP WITH TWO MODULES CONNECTED. CHANNEL A WAS INFUSING PRECEDEX AND CHANNEL B WAS INFUSING PROPOFOL. BOTH MEDICATIONS WERE CONNECTED TO THE PATIENT'S CENTRAL LINE VIA A MANIFOLD ALONG WITH ADDITIONAL UNSPECIFIED MEDICATION LINES BEING INFUSED FROM A DIFFERENT PUMP. AT 1600, THE PROPOFOL INFUSION WAS STOPPED. AT 1800, THE PRECEDEX INFUSION WAS STOPPED AND THE DEVICE TURNED POWERED OFF. A FEW MINUTES LATER, THE CLINICIAN NOTED THAT THE PATIENT'S MEAN ARTERIAL PRESSURE (MAP) WAS DECREASING. THE CLINICIAN ADMINISTERED ADDITIONAL NOREPINEPHRINE TO MAINTAIN MAP ABOVE 65MMHG. AT THIS TIME, THE CLINICIAN NOTED THAT MEDICATION WAS CONTINUING TO FLOW FROM THE POWERED DOWN PUMP AND MANUALLY CLAMPED THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520734 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown