BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 18993881 · Received March 28, 2024

    Report

    Report Number
    2016493-2024-21718
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 4, 2024
    Report Date
    May 7, 2024
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403811012
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: ANNEX B: B21 ANNEX C: C21 ANNEX D: D16 ADDITIONAL INFORMATION: ANNEX B: B17 ANNEX C: C20 ANNEX D: D15

    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 REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. H3 OTHER TEXT : NO PRODUCT WILL BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLLOWING ISSUE WAS OBSERVED ON THE DEVICE: "BROKEN-LPO-TC10006400 / BARREL CLAMP." REPORTED PROBLEM CAUSE DESCRIPTION: "NONE PROVIDED." HENCE, THE WORK PERFORMED IN THE DEVICE INCLUDES: "BROKEN - LPO - TC10006400 / BARREL CLAMP." THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    "IT WAS REPORTED THAT THE FOLLOWING ISSUE WAS OBSERVED ON THE DEVICE: ""BROKEN-LPO-TC10006400 / BARREL CLAMP."" REPORTED PROBLEM CAUSE DESCRIPTION: ""NONE PROVIDED."" HENCE, THE WORK PERFORMED IN THE DEVICE INCLUDES: ""BROKEN - LPO - TC10006400 / BARREL CLAMP." THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037823 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8110 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown