BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 PUMP MODULE 9.1.17.7

    MDR report key: 11183529 · Received January 17, 2021

    Report

    Report Number
    2016493-2021-06990
    Event Type
    Malfunction
    Date Received
    January 17, 2021
    Report Date
    March 13, 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¿S 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 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

    BD QUALITY ADVOCATE. THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. (B)(4). CASE DESCRIPTION: CALLER HAS AN 8100 MODULE GIVING HIM A 242.4030 ERROR. SN: (B)(4). CASE RESOLUTION: USED KA 12066 ALARIS INFUSION ERROR 242.4030. RECOMMEND TO REPLACE MOTOR CONTROL BOARD AND GAVE PART NUMBER. NO MOTOR MOVEMENT. TRANSFER TO COM FOR PRICING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79676 8100 PUMP MODULE 9.1.17.7 PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1