BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 15326229 · Received August 31, 2022

    Report

    Report Number
    2016493-2022-183511
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    August 8, 2022
    Report Date
    September 23, 2022
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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.

    Additional Manufacturer Narrative · 0

    CORRECTION : ANNEX B : B21. ANNEX C : C21. ANNEX D : D16. ADDITIONAL INFORMATION: DEVICE EVAL BY MANUFACTURER? & MANUFACTURER NARRATIVE. ANNEX A : A0709, A230502. ANNEX G : G0301204, G0405206. ANNEX B : B01, B14. ANNEX C : C07, C0201. ANNEX D : D15. 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. H3 OTHER TEXT : SEE MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP MODULE HAD A CHANNEL ERROR. NO FURTHER EVENT INFORMATION WAS MADE AVAILABLE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP MODULE HAD A CHANNEL ERROR. NO FURTHER EVENT INFORMATION WAS MADE AVAILABLE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2357398 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8015