BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 19296132 · Received May 13, 2024

    Report

    Report Number
    2016493-2024-26046
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 18, 2024
    Report Date
    September 11, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2718-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DESCRIBE EVENT OR PROBLEM ANNEX B: B22, ANNEX C: C20, ANNEX D: D16. UNIQUE DEVICE IDENTIFIER (UDI)#, ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD. ADDITIONAL INFORMATION: REMEDIAL ACTION REQUIRED, REMEDIAL ACTION #, ANNEX A: A040502, A0709, A230502, ANNEX B: B01, ANNEX C: C16, C0601, C23, ANNEX D: D01, D0301, D11, ANNEX G: G0301204, G02017, G0405206.

    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 SECTION H6 OF 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [DEPOT REPAIR];[AIR IN LINE]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [[SERVICE TYPE]];[AIR IN LINE]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450286 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown