BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 10694402 · Received October 16, 2020

    Report

    Report Number
    2016493-2020-23696
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Report Date
    September 29, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K091308
    Removal / Correction Number
    Z-2909-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE CUSTOMER REPORTED COMPLAINT OF THE KEYPAD BEING REPLACED DUE TO THE PCU MODULE NOT POWERING ON WAS CONFIRMED. TEST RESULTS IDENTIFIED THAT THE AC INDICATOR LIGHT ILLUMINATED AFTER PLUGGING IN THE POWER CORD. THE KEYPAD TURNED ON UNEXPECTEDLY WHEN CONNECT TO THE CAD PCU TEST FIXTURE #10013973 (EQ 111582) FOR FUNCTIONAL TESTING. FURTHER TESTING FOUND THAT THE SYSTEM ON KEY DID NOT FUNCTION. ALL OTHER KEYS ON THE KEYPAD WORKED AS INTENDED. DEVICE INSPECTION: EXTERNAL AND INTERNAL INSPECTION WAS PERFORMED ON (QTY 1 PRINTEC P/N TC10013664). DURING INTERNAL INSPECTION, THE KEYPAD WAS FOUND WITH SIGNS OF FLUID INGRESS WHERE THE FLEX CABLE MEETS THE CIRCUIT LAYER. DURING EXTERNAL INSPECTION, THE KEYPAD WAS IN GOOD CONDITION WITH NO ISSUES OBSERVED. ROOT CAUSE ANALYSIS: ELECTRICAL FAILURE ¿ DESIGN. 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. DEVICE HISTORY REVIEW: DEVICE HISTORY RECORD (DHR) REVIEWS ARE NOT REQUIRED FOR FIELD ACTION COMPLAINTS BECAUSE THE ROOT CAUSE OF THE ISSUE IS KNOWN, THE INVESTIGATION IS DOCUMENTED WITHIN A CAPA, AND A FIELD ACTION HAS BEEN INITIATED. H3 OTHER TEXT : ONLY A KEYPAD WAS PROVIDED FOR THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ALLEGEDLY A PCU MODULE WILL NOT POWER ON, AND THEREFORE, THE FRONT CASE KEYPAD WILL BE REPLACED. THERE WAS NO REPORTED 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 THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALLEGEDLY A PCU MODULE WILL NOT POWER ON, AND THEREFORE, THE FRONT CASE KEYPAD WILL BE REPLACED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154703 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1