BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 11615720 · Received April 5, 2021

    Report

    Report Number
    2016493-2021-502059
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Report Date
    March 22, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL SUPPORT (TS) PERFORMED TROUBLESHOOTING OVER THE PHONE TO DETERMINE ERROR CODE 132.3000. TS RECOMMENDED TO REPLACE SIO BOARD, RETURN MODULE TO THE FACTORY AND REPLACE TAMPER SWITCH. DEVICE HISTORY RECORD A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 04SEP2019. 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 (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE. A REVIEW OF THE COMPLAINT HISTORY RECORD WAS PERFORMED FOR THE (B)(6). WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. H3 OTHER TEXT : OVER THE PHONE TROUBLESHOTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE RECEIVED AN ALARM - ERROR CODE MESSAGE. THE ERROR CODE DISPLAYED WAS 132.3000. THE TECH RECOMMENDED REPLACING THE SIO BOARD AND THE TAMPER SWITCH THAT IS STUCK. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THE FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE RECEIVED AN ALARM - ERROR CODE MESSAGE. THE ERROR CODE DISPLAYED WAS 132.3000. THE TECH RECOMMENDED REPLACING THE SIO BOARD AND THE TAMPER SWITCH THAT IS STUCK. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512950 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1