BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11094781 · Received December 30, 2020

    Report

    Report Number
    2016493-2020-85780
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Report Date
    November 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. 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 TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE IS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CASE #: 00896275 CASE SUBJECT: NPI 8015 SYSTEM ERROR ACCOUNT NAME: 1ST CALL BIOMEDICAL ACCOUNT #: 10040313 ASSET NAME: 8015LS PCU DOM V9.19.1.2 A/B/G ASSET LOCATION: CONTACT: KEITH JACOBS CONTACT EMAIL: [email protected] CONTACT PHONE: 410-796-2800 CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: KEITH HAD A SYSTEM ERROR ON PCU8015 SN (B)(4) THE "SYSTEM ON RED ARROW" STAYS ON EVEN WHEN THE UNIT WAS TURNED OFF. AND THE UNIT KEPT ALARMING. FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8015 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: I RECOMMENDED KEITH TO REPLACE LOGIC BOARD. KEITH PREFERRED TO SEND UNIT IN FOR FLAT FEE REPAIR. HE WILL CONTACT COM DIRECTLY FOR RGA NUMBER TO SEND UNIT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559877 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1