BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 10475406 · Received September 1, 2020

    Report

    Report Number
    2016493-2020-03702
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 7, 2020
    Report Date
    August 7, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K091308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED COMPLAINT THAT THE (1) PCU KEYPAD WILL BE REPLACED DUE TO THE DEVICE NOT POWERING ON WAS CONFIRMED DURING FUNCTIONAL TESTING. INSPECTION: EXTERNAL AND INTERNAL INSPECTION WAS PERFORMED ON (QTY 1 P/N: TC10012515). DURING EXTERNAL INSPECTION, THE KEYPAD WAS OBSERVED WITH SIGNS OF FLUID INGRESS ON THE FLEX CABLE. DURING INTERNAL INSPECTION, THE KEYPAD WAS FOUND WITH SIGNS OF FLUID INGRESS WHERE THE FLEX CABLE MEETS THE CIRCUIT LAYER. LOG ANALYSIS RESULTS: N/A ¿ NO LOGS WERE PROVIDED. TEST RESULTS: THE FRONT CASE KEYPAD (QTY 1 P/N: TC10012515) WAS CONNECTED TO THE CAD PCU TEST FIXTURE #: 10013973 (EQ 111582) FOR FUNCTIONAL TESTING. THE RETURNED KEYPAD FAILED THE MAINTENANCE KEYPAD TEST DUE TO FAILING TO POWER ON THE DEVICE. THE PROXIMATE CAUSE OF THE CUSTOMER¿S EXPERIENCE WITH KEYPAD FAILURES IS SUSPECTED TO BE ASSOCIATED TO KEYPAD TRACE DAMAGE RESULTING FROM FLUID INGRESS ENTERING THE KEYPAD CIRCUIT LAYER. DEVICE HISTORY REVIEW: REVIEW OF THE PCU MODULE: 15350808 SERVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 09/26/2018. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE 10/21/2020 AND INDICATED THAT THIS DEVICE HAS NOT BEEN RETURNED TO SERVICE. REVIEW OF THE PRODUCTION FAILURE RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE THROUGH PRESENT. THE FAILURE RECORD SHOWED NO PRODUCTION FAILURE RECORDS WERE OPENED FOR THE SOURCE DEVICE. H3 OTHER TEXT : ONLY KEYPAD WAS RECEIVED FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE (1) PCU KEYPAD WILL BE REPLACED DUE TO THE DEVICE WILL NOT POWERING ON. THE CUSTOMER CONFIRM THAT THE ISSUE WAS FOUND DURING PREVENTIVE MAINTENANCE, NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE (1) PCU KEYPAD WILL BE REPLACED DUE TO THE DEVICE WILL NOT POWERING ON. THE CUSTOMER CONFIRM THAT THE ISSUE WAS FOUND DURING PREVENTIVE MAINTENANCE, NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941740 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1