BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 10322068 · Received July 24, 2020

    Report

    Report Number
    2016493-2020-01908
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Report Date
    July 6, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K091308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT THAT THE CUSTOMER IS REPLACING THE FRONT CASE DUE TO AN ¿UNRECOVERABLE ERROR 110.6021¿ (KEYBOARD FAILURE) WAS FOUND TO BE ASSOCIATED WITH A SUSPECTED FAILURE CAUSED FROM FLUID INGRESS IN THE CIRCUIT LAYER. EXTERNAL AND INTERNAL INSPECTION WAS PERFORMED ON (QTY 1 P/N TC10012515). DURING EXTERNAL INSPECTION, THE PRODUCT WAS OBSERVED WITH SIGNS OF FLUID INGRESS ON THE GROUND CABLE. DURING INTERNAL INSPECTION, THE PRODUCT WAS OBSERVED WITH SIGNS OF FLUID INGRESS ON THE ESD SHIELDING LAYER, THE GROUND CABLE, AND WHERE THE FLEX CABLE MEETS THE CIRCUIT LAYER. THE FRONT CASE KEYPAD (PCU) WAS CONNECTED TO THE CAD PCU TEST FIXTURE #10013973 (EQ 111582) AND POWERED ON IN MAINTENANCE MODE. THE KEYPAD TEST WAS SELECTED AND EACH KEY WAS INDIVIDUALLY TESTED. THE RESULTS FOUND THAT ALL BUTTONS WERE FUNCTIONING PROPERLY AND HAD NO ISSUES. PREVIOUS CAD FAILURE INVESTIGATIONS HAVE IDENTIFIED THIS ISSUE ASSOCIATED WITH FLUID INGRESS ENTERING THE KEYPAD RESULTING IN CONTAMINATED KEYPAD TRACES. CONSEQUENTLY, THE KEYPAD CIRCUIT LAYER BECOMES DAMAGED, CREATING AN OPEN OR SHORT CIRCUIT PRODUCING UNRESPONSIVE KEYPAD KEYS WHEN CORRESPONDING KEYS ARE PRESSED. 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 S/N (B)(6) SERVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 13FEB2019. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE 15SEP2020 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ASSY FR CASE W/ FOR THE PCU IS BEING REPLACED. CUSTOMER STATED ON INTAKE FORM, "UNRECOVERABLE ERROR 110*6021". TO DATE, THERE IS NO FURTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED. BECAUSE NO DEVICE OR DEVICE LOGS WERE RETURNED OR EXPECTED TO BE RETURNED, NO FAILURE INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ASSY FR CASE W/ FOR THE PCU IS BEING REPLACED. CUSTOMER STATES ON INTAKE FORM, "UNRECOVERABLE ERROR 110*6021", WHICH MEANS KEYBOARD FAILURE. TO DATE, THERE IS NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788008 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1