BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 17348619 · Received July 19, 2023

    Report

    Report Number
    2016493-2023-198391
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Date of Event
    June 26, 2023
    Report Date
    September 19, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801549
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. 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 REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. H3 OTHER TEXT : DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Additional Manufacturer Narrative · 0

    CORRECTION: UNIQUE DEVICE IDENTIFIER (UDI) #, PMA / 510(K)#. ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD. ADDITIONAL INFORMATION: DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 0

    OMIT: A0706 - CHARGING PROBLEM (2892). ROOT CAUSE: THE PROBABLE CAUSE OF THE REPORTED ERROR CODE 120.4610 WAS NOT IDENTIFIED DURING THE CUSTOMER CALL. HOWEVER, TO ADDRESS THE ISSUE, TECH SUPPORT RECOMMENDED EITHER REPLACE THE BATTERY OR SENDING THE UNIT TO THE REPAIR DEPOT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 8015 HAD ERROR CODE 120.4610. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 8015 HAD ERROR CODE 120.4610. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 8015 HAD ERROR CODE 120.4610. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40337 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801549

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown