BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 17067474 · Received June 5, 2023

    Report

    Report Number
    2016493-2023-176000
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    March 13, 2023
    Report Date
    August 3, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810046
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 0

    CORRECTION: ANNEX B : B21; ANNEX C : C21; ANNEX D : D16. ANNEX A: A1801, A230502, A0404, A040502, A0401. ANNEX G: G0301201,G02017, G04070, G04037, G0405206. ANNEX B: B01, B14. ANNEX C: C23, C07,C17, C070606, C0601. ANNEX D : D07, D15, D02, D11. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 23, AT 11:30 THE DEVICE HAD ACCURACY ISSUES. ALARIS INFUSION PUMP LOADED WITH PROPOFOL WAS FREE-FLOWING PROPOFOL DESPITE BEING PLACED ON "PAUSE". CASSETTE CLAMP OPENED AND RELOADED, CLOSED AGAIN BUT SAME RESULT. THERE WAS PATIENT INVOLVEMENT BUT THE HARM IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023 AT 11:30 THE DEVICE HAD ACCURACY ISSUES. ALARIS INFUSION PUMP LOADED WITH PROPOFOL WAS FREE-FLOWING PROPOFOL DESPITE BEING PLACED ON "PAUSE". CASSETTE CLAMP OPENED AND RELOADED, CLOSED AGAIN BUT SAME RESULT. THERE WAS PATIENT INVOLVEMENT BUT THE HARM IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233534 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8015| 8110