BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 10675764 · Received October 13, 2020

    Report

    Report Number
    2016493-2020-20320
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Report Date
    July 27, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-1359-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL SUPPORT TROUBLESHOOT WITH THE CUSTOMER OVER THE PHONE AND CONFIRMED 8015 ERROR 800.8000 TECH SUPPORT- REFLASH LOGIC BOARD; USED KA 11775 ALARIS INFUSION MEDICAL SAFETY NOTIFICATION MODEL 8015 SYSTEM ERROR 255-16-275 - 800.8000. WALKED BIOMED THROUGH ON REFLASHING THE SOFTWARE ON THE 8015 UNIT. THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM 06/14/2010 TO 9/17/2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS NOT RETURNED FOR SERVICING WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(6) WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION/SERVICING FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. THE TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT MULTIPLE COMPLAINTS WERE RECEIVED WITH SIMILAR SN (B)(6). WE WILL CONTINUE TO MONITOR ALL COMPLAINTS AND FAILURE MODES FOR UPWARD TRENDING AND TAKE APPROPRIATE ACTION AS REQUIRED. BASED ON THE TROUBLESHOOTING RESULTS, TECHNICAL SUPPORT DETERMINED THE PROXIMATE CAUSE OF THE CUSTOMER¿S REPORTED ISSUE REFLASH LOGIC BOARD; USED KA 11775 ALARIS INFUSION MEDICAL SAFETY NOTIFICATION MODEL 8015 SYSTEM ERROR 255-16-275 - 800.8000. WALKED BIOMED THROUGH ON REFLASHING THE SOFTWARE ON THE 8015 UNIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PC UNIT GAVE SYSTEM ERROR CODE 800.8000. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED. BECAUSE NO DEVICE OR DEVICE LOGS WERE RETURNED OR EXPECTED TO BE RETURNED, NO FAILURE INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM 06/14/2010 TO 9/17/2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS NOT RETURNED FOR SERVICING WHICH NOT 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 THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION/SERVICING FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. THE TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT MULTIPLE COMPLAINTS WERE RECEIVED WITH SIMILAR SN (B)(4). WE WILL CONTINUE TO MONITOR ALL COMPLAINTS AND FAILURE MODES FOR UPWARD TRENDING AND TAKE APPROPRIATE ACTION AS REQUIRED. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PC UNIT GAVE SYSTEM ERROR CODE 800.8000. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133022 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1