BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 10641599 · Received October 7, 2020

    Report

    Report Number
    2016493-2020-18386
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 13, 2020
    Report Date
    September 15, 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
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED COMPLAINT OF THE KEYPADS BEING REPLACED DUE TO ERROR CODE 110.6021 WAS EVALUATED. ERROR CODE 110.6021 WAS CONFIRMED ON 1 OUT OF 2 PCU KEYPADS. TEST RESULTS IDENTIFIED THAT THE AC INDICATOR LIGHTS ILLUMINATE ON BOTH KEYPAD AFTER PLUGGING IN THE POWER CORD. FRONT CASE KEYPAD ASSOCIATED TO SERIAL NUMBER (B)(6) HAD NO FAULTS. ALL KEYS ON THE KEYPAD WERE FUNCTIONING AS INTENDED. FUNCTIONAL TESTING COULD NOT BE PERFORMED ON THE FRONT CASE KEYPAD ASSOCIATED TO SERIAL NUMBER (B)(6). WHEN THE KEYPAD WAS CONNECTED TO CAD PCU TEST FIXTURE #10013973 (EQ 111582) THE DEVICE ALARMED SYSTEM ERROR 110.6021. AN INTERNAL INSPECTION WAS PERFORMED ON THE RETURNED KEYPADS. EACH LAYER OF THE FRONT CASES WAS REMOVED AND INSPECTED FOR ANOMALIES. THE KEYPADS WERE OBSERVED TO HAVE SIGNS OF FLUID INGRESS WHERE THE FLEX CABLE MEETS THE CIRCUIT LAYER. LOG SUMMARY: REVIEW OF THE PCU EVENT LOGS FOR THE DAY OF THE REPORTED EVENT CONFIRMED FOUR INSTANCES OF A SYSTEM MALFUNCTION WHICH CORRESPONDED TO SYSTEM ERROR 110.6020.1. REVIEW OF THE PCU ERROR LOGS CONFIRMED 20 INSTANCES OF THIS SYSTEM ERROR. THE 1ST ERROR OCCURRED ON 10SEPT2020 AT 12:46:54 PM AND THE LAST ERROR OCCURRED ON 15SEPT2020 AT 9:39:38 AM. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION TO H6: REMOVE CODE 4031, ADDED CODE 1198.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO PCUS HAD ERROR CODE 110.6021. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO PCUS HAD ERROR CODE 110.6021. NO FURTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PCUS HAD ERROR CODE 110.6021. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107184 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1