BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11043614 · Received December 20, 2020

    Report

    Report Number
    2016493-2020-73635
    Event Type
    Malfunction
    Date Received
    December 20, 2020
    Report Date
    August 8, 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

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. BASED ON THE FILE REVIEW, INFUSION PRODUCTS GLOBAL CUSTOMER SUPPORT OPERATIONS. 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

    ISSUE IN WIRELESS CARD- COMM FAILURE, WIRELESS CARD- NETWORK FAILURE. CASE #: 00795110 CASE SUBJECT: THERE WAS NO PATIENT INVOLVEMENT 8015 ERROR 600.6835 ACCOUNT NAME: SALVAGE MASTERS ACCOUNT #: 1009912 ASSET NAME: 8015LS PCU DOM V9.12.1 A/B/G R ASSET LOCATION: CONTACT: MATT BOWEN CONTACT EMAIL: [email protected] CONTACT PHONE: 800-558-1559 CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: BIOMED IS GETTING A 600.6835 ERROR FROM HIS 8015 UNIT. SN: (B)(4) FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8015 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: HAD BIOMED CONNECT THE 8015 TO THE SYSTEM MAINTENANCE PROGRAM. TRANSFERRED THE NETWORK CONFIG AND CYCLED POWER ON THE 8015 UNIT. ERROR WAS CLEARED AND UNIT OPERATES AS NORMAL. BIOMED ENDED CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508486 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1