BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 11597241 · Received March 31, 2021

    Report

    Report Number
    2016493-2021-501819
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Report Date
    March 16, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED. THIS DEVICE WAS EVALUATED AND REPAIRED THROUGH THE SERVICE REPAIR PROCESS. UPON VISUAL INSPECTION, THE SERVICE TECHNICIAN NOTED, THAT ERROR CODE 800.8000, REFLASHED POLO, PKB, AND MAIN SOFTWARE. BASED ON THE FINDINGS, SERVICE DETERMINED, THAT THE PROBABLE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO SOFTWARE ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED, THE DEVICE HAD A MANUFACTURE DATE OF 14FEB2018. THE REVIEW WAS PERFORMED, FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD 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. WHICH DID NOT CONFIRM, SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE DEVICE RECEIVED AN ALARM ERROR CODE MESSAGE, FOR DEVICE SOFTWARE. THE ERROR CODE DISPLAYED WAS 800.8000. THERE WAS NO PATIENT INVOLVEMENT

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND AN EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DEVICE SOFTWARE. ERROR CODE 800.000. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496076 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1