BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10689018 · Received October 16, 2020

    Report

    Report Number
    2016493-2020-22644
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Report Date
    April 19, 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
    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 PREVIOUSLY RETURNED FOR SERVICE. THE DATABASE SHOWED QUALITY NOTIFICATION #200145000 WAS OPENED FOR THE DEVICE WITHOUT CORRELATION TO THE REPORTED COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS RETURNED FOR SERVICING WHICH 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 PRODUCTION/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. THE TW COMPLAINT HISTORY REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT MULTIPLE COMPLAINTS WERE RECEIVED WITH SIMILAR SERIAL #. WE WILL CONTINUE TO MONITOR ALL COMPLAINTS AND FAILURE MODES FOR UPWARD TRENDING AND TAKE APPROPRIATE ACTION AS REQUIRED. CAPA REFERENCE:CA-(B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). PLEASE REFER TO THE FILE NUMBER 2018-014315-240248. (B)(4). ASSISTED (B)(6), TO ISOLATE PROBLEM FAULT WITH LOW PRESSURE READING DURING PATIENT-SIDE OCCLUSION TESTING. DEVICE SERIAL NUMBER (B)(4), UNABLE TO CALIBRATE PAST FIRST STEP (READING VOLTAGE DEFLECTION 0. CUSTOMER TO REPAIR/REPLACE THE LOGIC BOARD TO RESOLVE ISSUE OF CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156219 8100 ALARIS PUMP MODULE PUMP,INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1