BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 16694918 · Received April 6, 2023

    Report

    Report Number
    2016493-2023-144382
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    March 15, 2023
    Report Date
    November 26, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811012
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2719-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. THIS REPORT LISTS IMDRF ANNEX A, C, D, AND G CODES THAT ARE REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING SERVICING. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD BROKEN / DAMAGED - PLUNGER HEAD IS VERY DIFFICULT TO MOVE UP AND DOWN. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD BROKEN / DAMAGED - PLUNGER HEAD IS VERY DIFFICULT TO MOVE UP AND DOWN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795500 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown