BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10703447 · Received October 20, 2020

    Report

    Report Number
    2016493-2020-24480
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Report Date
    March 13, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    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 NOT PERFORMED BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED. A DHR (DEVICE HISTORY RECORD) REVIEW CANNOT BE COMPLETED AS THE SERIAL NUMBER WAS NOT OBTAINED UPON RECEIPT OF THE COMPLAINT. ADDITIONALLY, A HISTORICAL REVIEW OF COMPLAINTS IN TRACKWISE CANNOT BE CONDUCTED CAPA REFERENCE: (B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CASE ID: (B)(4). CASE STATUS: OPEN. SUMMARY: ERROR CODE 211-2000 ON 8100 UNIT. CASE NOTES: (B)(4). NPI. CUSTOMER MICHAEL CALLED IN FOR HELP ON 8100 UNIT HAS ERROR CODE 211-2000 WHICH IS A UNSPECIFIED COMMUNICATION ERROR HAS A BAD LOGIC BOARD WILL NEED TO BE REPLACE CONFIRM PART NUMBER TO CUSTOMER FOR THE LOGIC BOARD. ALSO CUSTOMER HAS A 8015 UNIT WHEN POWER UNIT ON GETS A RED ARROW BY THE SYSTEM ON BUTTON. WHICH IS A WATCHDOG ERROR UNIT WILL HAVE TO COME IN FOR SERVICES REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168650 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1