BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11300050 · Received February 9, 2021

    Report

    Report Number
    2016493-2021-25114
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Report Date
    July 22, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE THAT THE DISPLAY BOARD IS BEING REPLACED DUE TO THE RECALL FOR DIM SEGMENTS COULD NOT BE CONFIRMED; NO PRODUCT OR DEVICE LOGS WERE RETURNED TO CUSTOMER ADVOCACY (CAD) FOR INVESTIGATION. THE FILE WAS OPENED TO DOCUMENT THE ISSUE THAT WAS REPORTED. NO FURTHER INVESTIGATION OF THIS EVENT IS POSSIBLE AT THIS TIME; HOWEVER BD IS CURRENTLY INVESTIGATING THE DIM SEGMENT ISSUE WITH CAPA PR 1143616. THE ALARIS PUMP MODULE IS TYPICALLY USED FOR TREATMENT. THE FILE MAY BE CLOSED BASED ON THE ABOVE FACTS. 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

    IT WAS REPORTED THE DISPLAY BOARD IS BEING REPLACED DUE TO THE RECALL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197263 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1