BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10753202 · Received October 29, 2020

    Report

    Report Number
    2016493-2020-29357
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Report Date
    April 11, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403222054
    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 DEVICE WAS NOT RETURNED FOR SERVICE. 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 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. CAPA REFERENCE: (B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CASE ID: 7002015658 CASE STATUS: OPEN SUMMARY: NPI 8100 210.5020 ERROR CASE NOTES: PROBLEM DESCRIPTION PROBLEM DESCRIPTION 05/15/2018 11:19:35 DDMANANS USE TRACKWISE NUMBER 2018-012864-237967 PER JOHN ROCCIOLO HI, OUR MAILBOX DIDN¿T GET UPDATED CORRECTLY, GO AHEAD KEEP THE FILE THAT MARJIE CREATED AND CANCEL MINE, THANKS. JOHN ROCCIOLO SPEC, CUSTOMER ADVOCACY COMPLAINT MANAGEMENT ____________________ PROBLEM DESCRIPTION 04/13/2018 07:11:30 DDMANANS DISREGARD LAST ENTRY. 2018-013201-238389 JOHN ROCCIOLO SPEC, CUSTOMER ADVOCACY COMPLAINT MANAGEMENT ____________________ PROBLEM DESCRIPTION 04/11/2018 11:44:39 DDMANANS THE FILE NUMBER FOR THIS L2 COMPLAINT IS 2018-012864-237967. MARJIE L. NORTE CUSTOMER ADVOCACY, CLINICAL SPECIALIST ____________________ PROBLEM DESCRIPTION 04/11/2018 09:33:10 DDMANANS SN (B)(4) 8100 210.5020 ERROR. BIOMED REPLACED THE LOGIC BOARD AND MOTOR CONTROL BOARD AND STILL SAME ERROR. RECOMMEND HE TRY ANOTHER DISPLAY BOARD. IF ERROR STILL PERSIST, THE DOOR HARNESS CABLE MUST BE REPLACED. BIOMED WILL TRY ANOTHER DISPLAY BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223948 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403222054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other