BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11249554 · Received January 29, 2021

    Report

    Report Number
    2016493-2021-20080
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Report Date
    July 14, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    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 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 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 8100 ERROR 200.5040. ACCOUNT NAME: NYU LANGONE HOSPITAL - BROOKLYN (FKA NYU LUTHERAN MEDICAL CENTER) ACCOUNT #: (B)(6). ASSET NAME: 8100 PUMP MODULE V9.33.0 ASSET LOCATION: (B)(6). PATIENT OR USER INVOLVEMENT: NO. PATIENT OR USER HARM: NO. CASE DESCRIPTION: CUSTOMER HAS DEVICE 8100 (S/N (B)(4)), NEEDING OPERATE FIRMWARE UPDATED FROM VERSION 9.33. CASE RESOLUTION: CUSTOMER HAS DEVICE 8100 (S/N (B)(4)), NEEDING OPERATE FIRMWARE UPDATED FROM VERSION 9.33. CHECK THE SETUP OF SYSTEM MAINTENANCE FIRMWARE IN THE NETWORK CONFIGURATION PACKAGE. ASSISTED CUSTOMER TO STEP THROUGH THE FLASH TASK IN SYSTEM MAINTENANCE. CHECK TO VERIFY THE DEVICE CONNECTED TO SYSTEM MAINTENANCE. EXPLAINED AND STEP CUSTOMER THROUGH THE FLASH TASK PROCESS FOR UNDERSTANDING. DEVICE CONNECTED TO FLASH TASK SUCCESSFULLY. CUSTOMER WILL CALL BACK IF ANY FURTHER ISSUES AND/OR CONCERNS. END CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149885 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1