BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 10606777 · Received September 30, 2020

    Report

    Report Number
    2016493-2020-15247
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Report Date
    September 2, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K091308
    Removal / Correction Number
    Z-2909-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5. THE REPORTED ISSUE OF PCU FRONT CASE IS BEING REPLACED FOR UNSPECIFIED KEYPAD ISSUES IS CONFIRMED BASED ON THE FIELD ACTION. EXTERNAL AND INTERNAL INSPECTION WAS PERFORMED ON THE FRONT CASE KEYPAD (QTY 9 GM P/N TC10008335), (QTY 1 GM P/N TC10003750) AND (QTY 12 GM P/N TC10008582) DURING EXTERNAL INSPECTION, THE RETURNED KEYPAD WAS OBSERVED WITH SIGNS OF A CREASE ON THE FLEX CABLE. DURING INTERNAL INSPECTION, THE RETURNED KEYPAD WAS OBSERVED WITH A CREASE WHERE THE FLEX CABLE MEETS THE CIRCUIT LAYER. TEST RESULTS: THE FRONT CASE KEYPAD (QTY 9 GM P/N TC10008335), (QTY 1 GM P/N TC10003750) AND (QTY 12 GM P/N TC10008582) WERE CONNECTED TO A CAD PCU TEST FIXTURE #10013973 FOR FUNCTIONAL TESTING. THE RETURNED KEYPADS FAILED THE MAINTENANCE KEYPAD TEST DUE TO VARIOUS UNRESPONSIVE SOFT KEYS. THE KEYPAD¿S AC INDICATOR LIGHT DID NOT ILLUMINATE AS EXPECTED AFTER PLUGGING IN THE POWER CORD AND THE SYSTEM ON KEY DID NOT FUNCTION AS INTENDED BUT WAS OBSERVED WITH THE ISSUES MENTIONED ABOVE. ELECTRICAL FAILURE ¿ DESIGN. 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 KEYPADS WERE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 25 PCU FRONT CASE IS BEING REPLACED FOR UNSPECIFIED KEYPAD ISSUES. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    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 25 PCU FRONT CASE IS BEING REPLACED FOR UNSPECIFIED KEYPAD ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070048 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1