BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 10660232 · Received October 11, 2020

    Report

    Report Number
    2016493-2020-18233
    Event Type
    Malfunction
    Date Received
    October 11, 2020
    Report Date
    September 17, 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
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CONCLUSION: THE CUSTOMER REPORTED COMPLAINTS OF KEYPADS BEING REPLACED DUE TO PCUS POWERING ON BY THEMSELVES, DISPLAYING ERROR CODE 110.6020 AND HAVING FAULTY KEYS WAS EVALUATED. TEST RESULTS IDENTIFIED THAT THE AC INDICATOR LIGHT DID NOT ILLUMINATE ON 1 OUT OF 5 KEYPADS AFTER PLUGGING IN THE POWER CORD. THE SYSTEM ON KEY DID NOT FUNCTION ON 4 OUT OF THE 5 KEYPADS TESTED. ONE KEYPAD HAD NO FAULTS. FOUR KEYPADS POWERED ON UNEXPECTEDLY WHEN CONNECTED TO THE CAD PCU TEST FIXTURE #10013973 (EQ 111582) FOR FUNCTIONAL TESTING. NONE OF THE KEYPADS TESTED DISPLAYED ERROR CODE 110.6020. DEVICE INSPECTION: EXTERNAL AND INTERNAL INSPECTION WAS PERFORMED ON (QTY 1 PRINTEC P/N TC10012515 AND QTY 4 PRINTEC P/N TC10013664). DURING INTERNAL INSPECTION, THE KEYPADS WERE FOUND WITH SIGNS OF FLUID INGRESS WHERE THE FLEX CABLE MEETS THE CIRCUIT LAYER AND BROKEN TRACES (TRACE 19 AND 20). 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 FRONT CASE KEYPAD ASSEMBLIES WERE PROVIDED FOR THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE POINT OF CARE UNIT (PCU) POWERED ON ITSELF, TWO UNITS DID NOT POWER ON, ONE HAD ERROR CODE 110.6020 AND SOME BUTTONS DID NOT WORK ON KEYPAD FOR ONE UNIT. THEREFORE, FIVE POINT OF CARE UNIT (PCU) FRONT CASES WITH KEYPADS NEEDED TO BE REPLACED.

    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 ONE POINT OF CARE UNIT (PCU) POWERED ON ITSELF, TWO UNITS DID NOT POWER ON, ONE HAD ERROR CODE 110.6020 AND SOME BUTTONS DID NOT WORK ON KEYPAD FOR ONE UNIT. THEREFORE, FIVE POINT OF CARE UNIT (PCU) FRONT CASES WITH KEYPADS NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124652 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1