BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 10917537 · Received November 30, 2020

    Report

    Report Number
    2016493-2020-51364
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Report Date
    November 27, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS-USED INFORMATION WERE REVIEWED FOR THE SAP AND TRACK WISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE SOURCE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN 15356037 WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    ERROR CODE WHEN PLUGGED INTO AC PWR- (B)(6) 2018 14:06:10 (B)(6) NO CHARGE/ OOB REPAIR . NPI. (B)(6) 2018 12:10:24 (B)(6). AFTER INVESTIGATION, THE DEVICE MODULE RUN TIME WAS 0 HOURS. THIS DEVICE MEETS THE CRITERIA PER 1601-011-000 OUT-OF-BOX FAILURE PROCESSING DOCUMENT # 10000053419 FOR RESTOCKING BACK TO FINISHED GOODS WAREHOUSE. (B)(6) 2018 07:37:30 (B)(6). INVESTIGATION SUMMARY: REPORT ERROR CODE WHEN PLUGGED INTO AC PWR WAS CONFIRMED. AS RECEIVED PCU WAS DETECTED ERROR 120.4630 (PSP_SS = 120, PSP_CHARGER_FET_ERROR = 4630) UPON THE COMPLETION OF THE POWER ON SELF TEST. FAILURE INVESTIGATION ISOLATED THE CAUSE OF REPORT ERROR CODE WHEN PLUGGED INTO AC POWER TO A POWER SUPPLY BOARD. FINDING: 1. THE CERAMIC CAPACITOR C175 AND C70 (PART NUMBER 823935-474 - CAP CER X7R 0.47UF 100V 10% 1210) WERE SEVERELY DAMAGED. 2. EXTREMELY HEAT FROM THE CAPACITOR ALSO SMOKE THE BOARD. CONCLUSION: DEFECTIVE THE CERAMIC CAPACITOR C175 AND C70 ( PART NUMBER 823935-474 - CAP CER X7R 0.47UF 100V 10% 1210) ARE THE MAIN CAUSE OF REPORT ERROR CODE WHEN PLUGGED INTO AC PWR REWORK: 1. RECOMMEND REPLACING POWER SUPPLY BOARD PART NUMBER TC10006929. 2. RECOMMEND REPLACING HANDLE TOP 8015 PCU M2 TC10010818. DISPOSITION ROUTE TO SERVICE FOR NORMAL PROCESS.

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS-USED INFORMATION WERE REVIEWED FOR THE SAP AND TRACK WISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE SOURCE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). CONCLUSION: DEFECTIVE THE CERAMIC CAPACITOR C175 AND C70 ( PART NUMBER 823935-474 - CAP CER X7R 0.47UF 100V 10% 1210) ARE THE MAIN CAUSE OF REPORT ERROR CODE WHEN PLUGGED INTO AC PWR. REWORK: RECOMMEND REPLACING POWER SUPPLY BOARD PART NUMBER TC10006929. RECOMMEND REPLACING HANDLE TOP 8015 PCU M2 TC10010818. DISPOSITION: ROUTE TO SERVICE FOR NORMAL PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381966 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown