BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10694897 · Received October 18, 2020

    Report

    Report Number
    2016493-2020-22791
    Event Type
    Malfunction
    Date Received
    October 18, 2020
    Report Date
    March 1, 2018
    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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMPLAINT THAT A PUMP MODULE DEVICE ALARMED FOR FLUID SIDE OCCLUSION WAS CONFIRMED AND REPLICATED DURING THE INVESTIGATION. LOG ANALYSIS NOTED THAT THE PUMP MODULE HAD ALSO EXPERIENCED MULTIPLE FLUID SIDE OCCLUSION ALARMS. TESTING FOUND THE RETURNED PUMP MODULE WOULD ALARM FOR OCCLUDED - FLUID SIDE WAS ALSO FAILING ALARIS SYSTEM MAINTENANCE (ASM) FLUID SIDE PRESSURE SENSOR OUTPUT. DURING INSPECTION THE UPPER (BOTTLE SIDE) PRESSURE SENSOR HOUSING WAS FOUND TO BE SEPARATED AND WAS SNAPPED BACK TOGETHER AND THE PRESSURE SENSORS RETESTED. BOTH PRESSURE SENSORS WERE NOW FOUND TO BE IN SPECIFICATION. PREVIOUS INVESTIGATIONS INTO SEPARATION OF THE PRESSURE SENSOR BODY HAVE CONFIRMED SIGNIFICANT DIFFERENCES IN THE MOUNTING CHARACTERISTICS OF LATCHING MECHANISM BETWEEN THE OLDER-STYLE FSO PRESSURE SENSOR AND THE NEWER-STYLE FSA PRESSURE SENSOR HOUSING. THE FEATURES ON THE OLDER-STYLE FSO PRESSURE SENSOR HOUSING APPEAR TO CONTRIBUTE TO A MORE ROBUST AND SECURE HOUSING. IT IS BEING RECOMMENDED THAT BOTH PRESSURE SENSORS BE REPLACED AS A PREVENTATIVE MEASURE. 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 REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED THAT THIS DEVICE WAS INVOLVED IN A SERVICING FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. THE TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT MULTIPLE COMPLAINTS WERE RECEIVED WITH SIMILAR SN (B)(4). WE WILL CONTINUE TO MONITOR ALL COMPLAINTS AND FAILURE MODES FOR UPWARD TRENDING AND TAKE APPROPRIATE ACTION AS REQUIRED. CAPA REFERENCE: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE ALARMED FOR FLUID SIDE OCCLUSION DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159696 8100 ALARIS PUMP MODULE PUMP,INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1