BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 10730890 · Received October 23, 2020

    Report

    Report Number
    2016493-2020-20256
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Date of Event
    September 3, 2020
    Report Date
    October 7, 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
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H6, H7, H9. UPDATED: H3.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED COMPLAINT OF EXPERIENCING A DEFECTIVE KEYPAD WAS CONFIRMED. THE REPORTED SYSTEM ERROR CODE: 133.6090 WAS NOT REPLICATED DURING TESTING. INSPECTION: EXTERNAL AND INTERNAL INSPECTION WERE PERFORMED ON THE CUSTOMER RETURNED PCU DEVICE (B)(6). DURING EXTERNAL INSPECTION, THE PCU DEVICE WAS RECEIVED WITH INSTRUMENT SEAL MISSING. THE RIGHT (MALE) IUI WAS OBSERVED TO BE IN GOOD CONDITION. THE LEFT (FEMALE) IUI WAS OBSERVED TO BE IN GOOD CONDITION. DURING INTERNAL INSPECTION, THE KEYPAD WAS OPENED AND OBSERVED WITH SIGNS OF FLUID INGRESS AND THERE WERE NO OTHER OBVIOUS ISSUES OBSERVED. LOG ANALYSIS RESULTS: THE PCU ERROR LOG CONFIRMED 2 ENTRIES OF THE SYSTEM ERROR CODE: 133.6090 (MAIN SPEAKER FAILURE) ON SEPTEMBER 03, 2020 AT 8:28:42 AM AND SEPTEMBER 06, 2020 AT 2:58:39 PM. EACH OCCURRENCE WAS ACCOMPANIED WITH THE SYSTEM ERROR CODE 120.4370.5 (LOW VOLTAGE ON 8V SUPPLY LINE) (LOG ONLY). THE OBSERVED LOG ONLY ERROR IS INDICATIVE OF A SHORT CIRCUIT CONDITION IN WHICH THE 8-VOLT LINE IS TEMPORARILY PULLED LOW. INSPECTION OF THE PCU DEVICE OBSERVED NO ANOMALIES THAT WOULD INDICATE A SHORT CONDITION. TEST RESULTS: THE FRONT CASE KEYPAD OF THE CUSTOMER RETURNED PCU DEVICE WAS CONNECTED TO A CAD PCU TEST FIXTURE #10013973 (EQ 111582) FOR FUNCTIONAL TESTING. THE KEYPAD FAILED THE MAINTENANCE KEYPAD TEST DUE TO BEING UNABLE TO POWER ON THE DEVICE. THE FIXTURE WAS POWERED ON WITH A KNOWN GOOD KEYPAD AND THEN REPLACED WITH THE CUSTOMER¿S RETURNED PCU KEYPAD TO COMPLETE THE MAINTENANCE KEYPAD TEST. THE RESULTS FOUND ALL SOFT KEYS TO BE FUNCTIONING EXCEPT FOR THE SYSTEM ON KEY. A KNOWN GOOD KEYPAD WAS INSTALLED ONTO THE CUSTOMERS RETURNED PCU AND FOUND TO BE FUNCTIONING AS INTENDED. THE SYSTEM ERROR CODE DID NOT OCCUR WHEN A NEW KEYPAD WAS INSTALLED ONTO THE CUSTOMER¿S RETURNED PCU. THE PROXIMATE CAUSE OF THE CUSTOMER¿S EXPERIENCE WITH A DEFECTIVE PCU IS ASSOCIATED TO KEYPAD TRACE DAMAGE RESULTING FROM FLUID INGRESS ENTERING THE KEYPAD CIRCUIT LAYER. THE ROOT CAUSE OF THE SYSTEM ERROR CODE 133.6090 (MAIN SPEAKER FAILURE) CANNOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DEFECTIVE PCU (8015) KEYPAD RESULTING IN THE DEVICE TURNING ON BY ITSELF. AFTER THE PCU HAD TURNED ON BY ITSELF, A SYSTEM ERROR CODE 133.6090 APPEARED ON THE DISPLAY. THE BIOMEDICAL ENGINEER CONFIRMED THAT THE "POWER ON" BUTTON WAS DEFECTIVE. THERE WAS NO PATIENT HARM. THE ISSUES WERE NOTED PRIOR TO PATIENT USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A DEFECTIVE PCU (8015) KEYPAD RESULTING IN THE DEVICE TURNING ON BY ITSELF. AFTER THE PCU HAD TURNED ON BY ITSELF, A SYSTEM ERROR CODE 133.6090 APPEARED ON THE DISPLAY. THE BIOMEDICAL ENGINEER CONFIRMED THAT THE "POWER ON" BUTTON WAS DEFECTIVE. THERE WAS NO PATIENT HARM. THE ISSUES WERE NOTED PRIOR TO PATIENT USE.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A DEFECTIVE PCU (8015) KEYPAD RESULTING IN THE DEVICE TURNING ON BY ITSELF. AFTER THE PCU HAD TURNED ON BY ITSELF, A SYSTEM ERROR CODE 133.6090 APPEARED ON THE DISPLAY. THE BIOMEDICAL ENGINEER CONFIRMED THAT THE "POWER ON" BUTTON WAS DEFECTIVE. THERE WAS NO PATIENT HARM. THE ISSUES WERE NOTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189823 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1