BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11036016 · Received December 18, 2020

    Report

    Report Number
    2016493-2020-73379
    Event Type
    Malfunction
    Date Received
    December 18, 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. 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. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CASE DESCRIPTION: LARRY HAD A LVP8100 SN (B)(4) FAILED RATE TEST DURING PM. FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT FAILURE PROBLEM TYPE: 8100 FAILURE MODE: TROUBLESHOOTING/ ERROR CODES CASE RESOLUTION: I REVIEWED THE RATE CALIBRATION PROCESS WITH LARRY AND FOUND OUT THE RATE CALIBRATION SET (8100-RCS) WAS OVER USED (ABOUT 80 TIMES). I ADVISED LARRY 8100-RCS IS ONLY GOOD FOR 60 USES. LARRY WILL REPLACE NEW 8100-RCS AND TEST IT AGAIN. IF THE SET DID NOT RESOLVE THE ISSUE, LARRY WILL REPLACE BEZEL ASSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502746 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1