BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11034062 · Received December 18, 2020

    Report

    Report Number
    2016493-2020-72163
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Report Date
    July 16, 2019
    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 · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE 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 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 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

    CASE #: (B)(4), CASE SUBJECT: NPI 8015 NOT CONNECTING TO SYSTEMS MAINTENANCE ACCOUNT NAME: WEED ARMY COMMUNITY HOSPITAL ACCOUNT #: 1021395 ASSET NAME: 8015LS PCU DOM V9.19.1.2 A/B/G/N ASSET LOCATION: CONTACT: (B)(6) CONTACT EMAIL: (B)(6) CONTACT PHONE: (B)(6) CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: CUSTOMER REPORTS THEIR 8015 (SN: (B)(4)) NOT CONNECTING TO SYSTEMS MAINTENANCE. FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8015 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: RECOMMENDED CUSTOMER CONNECT ANOTHER 8015 TO VERIFY PROPER SET UP. NEXT I INFORMED THE CUSTOMER THIS IS MOST LIKELY DUE TO THE SERIAL INPUT OUTPUT BOARD. RECOMMENDED REMOVING A KNOWN GOOD BOARD AND SWAPPING IN THE AFFECTED 8015. IF UNIT CONNECTS, REPLACE THE BOARD. IF UNIT STILL DOES NOT CONNECT THEN THEY ARE LOOKING AT A LOGIC BOARD ISSUE. PROVIDED PART NUMBER OF SIO BOARD. CUSTOMER WILL MOVE FORWARD WITH MY RECOMMENDATIONS. ENDED CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499245 8015 ALARIS SYSTEM PC UNIT PUMP,INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1