BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11064982 · Received December 23, 2020

    Report

    Report Number
    2016493-2020-79608
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Report Date
    September 13, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    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 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

    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: ALAN HAD A LVP8100 SN (B)(4) FAILED RATE CALIBRATION. FAILURE DEVICE TYPE: ALARIS SYSTEM INSTRUMENT. FAILURE PROBLEM TYPE: 8100. FAILURE MODE: TROUBLESHOOTING/ ERROR CODES. CASE RESOLUTION: I REVIEWED THE CALIBRATION PROCESS WITH (B)(6). HE WAS NOT ABLE TO CONFIRM THE EXPIRATION DATE FOR THE CALIBRATION SET AND HE COULD NOT ASSURE IT WAS 8100-RCS (RATE CALIBRATION SET). I ADVISED (B)(6) TO REPLACE THE SET AND MAKE SURE IT IS 8100-RCS. (B)(6) WILL USE 8100-RCS. IF HE STILL HAVE PROBLEM, HE WILL CALL ME BACK AND REFER TO THIS CASE NUMBER. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533014 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1