BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 11589947 · Received March 30, 2021

    Report

    Report Number
    2016493-2021-31444
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    August 14, 2020
    Report Date
    August 26, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE REPORT OF AN OVERINFUSION WAS CONFIRMED IN THE PCA EVENT LOG. THE PCA MODULE EVENT LOG SHOWS PCA S/N (B)(4) WAS IN USE AND INFUSING A PCA DOSE ONLY INFUSION. EACH PCA DOSE DELIVERED 1ML AT 150ML/HR. AT 1:37 AM, THE USER CHANGED THE SYRINGE TO A 30ML BD SYRINGE WITH 30.2714ML DETECTED AND STARTED THE INFUSION, HOWEVER NOW EACH PCA DOSE DELIVERED 5ML AT 150MLHR, INSTEAD OF THE PREVIOUS 1ML AT 150ML/HR. THE INFUSION RAN FROM 1:41 AM UNTIL 2:44 AM, WHEN THE INFUSION STOPPED DUE TO THE SYRINGE BEING EMPTY, AFTER DELIVERING 6 PCA DOSE REQUESTS OF 5ML EACH. DEVICE INSPECTION: N/A, ONLY THE PCA EVENT LOG WAS RECEIVED FOR INVESTIGATION. THE INCIDENT ADMINISTRATION SET WAS NOT RETURNED AND COULD NOT BE INSPECTED. ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THE REPORTED OVERINFUSION WAS IDENTIFIED AS DUE TO USER PROGRAMMING. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 12JAN2016. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR PCU S/N (B)(4) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED FOR THE PCU S/N (B)(4) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. DEVICE NOT RETURNED - LOG REVIEW ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICIAN CHANGED THE DOSE ON PATIENT'S MORPHINE PATIENT CONTROLLED ANALGESIA PUMP AT 0136 TO 1MG WITH A 10-MINUTE LOCKOUT INTERVAL. AT APPROXIMATELY 0251, THE DEVICE ALARMED AND FOUND THAT THE 30ML SYRINGE INFUSION WAS EMPTY. THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488293 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1