BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10817258 · Received November 10, 2020

    Report

    Report Number
    3012307300-2020-11317
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Date of Event
    September 1, 2020
    Report Date
    November 10, 2020
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF A SMITHS MEDICAL CADD EXTENSION SET FOR A LIFE SUSTAINING INFUSION (REMODULIN MDV 10MG/M, DOSE AMOUNT 276 NG/KG/MIN), PATIENT REPORTED THAT TWICE IN THE PAST TWO WEEKS, HIS EXTENSION SET TUBING WAS LEAKING AT THE FILTER. THE REPORTER INDICATED THAT THE PATIENT WAS ADVISED THAT WHEN THIS OCCURS, THE TUBING SHOULD BE CHANGED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283540 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR