BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 12757702 · Received November 7, 2021

    Report

    Report Number
    2016493-2021-69126
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 14, 2021
    Report Date
    May 18, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ANNEX A: A1601, ANNEX G: G0600101, ANNEX B: B21, ANNEX C: C21, ANNEX D: D16. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL? RETURNED TO MANUFACTURER ON, DEVICE RETURN TO MANUF.? DEVICE EVAL BY MANUFACTURER? ADDITIONAL INFORMATION: ANNEX A: A090202, A040502, A070908, ANNEX G: G02017, G03005, G05005, ANNEX B: B01, B14, ANNEX C: C16, C0201, C0601, ANNEX D: D01, D02, D03. H3 OTHER TEXT: SEE MANUFACTURER NARRATIVE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD MOTOR STALL ERROR, 242.4030. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD MOTOR STALL ERROR, 242.4030. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657452 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown