BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11043871 · Received December 21, 2020

    Report

    Report Number
    2016493-2020-73864
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Report Date
    August 5, 2019
    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. BASED ON THE FILE REVIEW, NO FURTHER ESCALATION IS REQUIRED PER 1501-006-000 SWI-SD-INF 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 THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    BROKEN/DAMAGED- 08/05/2019 10:48:30 RFC_REPAIRS (RFC_REPAIRS) 8100VDXEN9117 8100 PUMP MODULE V9.1.17.7 FACTORY RECALL FR110 08/13/2019 05:15:19 CLELIA FLORES (CLFLORES) EST MNR 08/13/2019 05:21:39 BINH TAN NGUYEN (BTNGUYEN) NOT A TRUE 90 DAYS 09/11/2019 13:00:10 CRISLEIVY PENA (CRPENA) UPDATED FROM SRV TO MNR FOR THE MINOR REPAIR NEEDED PER CLELIA FLORES, SERVICE TECH. REPAIR APPROVED BY CONNY YEUNG, BIOMED, AT [email protected] FOR $230. NEW PO# 3000331297. 09/13/2019 10:10:18 ANNETTE A MENDEZ (AMENDEZ) 9632001960920413730700119242561708.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515511 8100 ALARIS PUMP MODULE PUMP,INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1