BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 16021758 · Received December 21, 2022

    Report

    Report Number
    2016493-2022-239938
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    November 28, 2022
    Report Date
    February 3, 2023
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403424267
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 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

    CORRECTION: DESCRIBE EVENT OR PROBLEM, REPORT SOURCE, REPORT SOURCE OTHER. ANNEX B: B21. ANNEX C: C21. ANNEX D: D16. ADDITIONAL INFORMATION: DEVICE EVAL BY MANUFACTURER? ANNEX A: A0709, A0509, A070903, A0401, A0404. ANNEX G: G03012, G0201204, G04052, G04055, G0204002. ANNEX B: B01, B14. ANNEX C: C07, C0201. ANNEX D: D15, D02 H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD KEYPAD ERROR AND SYRINGE POSITION SENSOR ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD KEYPAD ERROR AND SYRINGE POSITION SENSOR ERROR. THERE WAS PATIENT INVOLVEMENT BUT IMPACT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1981665 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8015