BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11034317 · Received December 18, 2020

    Report

    Report Number
    2016493-2020-72187
    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 RETURNED FOR SERVICING WHICH 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 WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CASE #: 00769862 CASE SUBJECT: NPI 8015 ERROR 600.6875 ACCOUNT NAME: GRANDVIEW HOSPITAL ACCOUNT #: 1272200 ASSET NAME: 8015LS PCU DOM V9.19.1.2 A/B/G/N ASSET LOCATION: CONTACT: DANNY KAMPHAUS CONTACT EMAIL: (B)(6) CONTACT PHONE: 937-723-3815 CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: DAN HAD ERROR 600.6875 ON PCU8015 SN (B)(4). FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8015 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: DANNY TRANSFER NETWORK CONFIGURATION ON THE PCU8015. AND RECEIVED AN ERROR "SELECTED PCU RF CARD NOT SUPPORT. I RECOMMENDED DANNY TO REPLACE NETWORK CARD. DANNY WILL REPLACE NETWORK CARD OR THE NETWORK CARD EXTENSION BOARD. IF HE STILL HAVE PROBLEM, HE WILL CALL ME BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499547 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1