BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 19508671 · Received June 11, 2024

    Report

    Report Number
    2016493-2024-28909
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    May 16, 2024
    Report Date
    August 14, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K211218
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THROUGH INVESTIGATION OF THE DEVICES THAT THE INITIALLY REPORTED SUSPECT DEVICE WITH SERIAL NUMBER# (B)(6) IS A CONCOMITANT AND THIS FILE HAS CAPTURED THE CORRECT SUSPECT DEVICE WITH SERIAL NUMBER# (B)(6) AS PER INVESTIGATION REPORT. OMIT: C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED. 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 THIS MDR REPORT.

    Additional Manufacturer Narrative · 0

    BD TECHNICAL SUPPORT TROUBLESHOOT WITH CUSTOMER OVER THE PHONE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP INFUSED FASTER THAN EXPECTED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER ALSO WANTED SOME ASSISTANCE UNDERSTANDING THE LOGS THAT THEY SENT: "IF I AM READING THESE CORRECTLY LINES 373-379 THE PUMP WAS PROGRAMMED WITH A DOSE OF 354 MG, BSA OF 2, A VTBI OF 559 AND A RATE OF 186.3ML/HR FROM 6/21 1141-6/21 1411 AND SHOULD HAVE INFUSED 460.1 ML IN HOWEVER THE BAG WAS FULL AT 1411 AND THEREFORE WE SWITCHED PUMPS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP INFUSED FASTER THAN EXPECTED. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295824 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8015| 8100