BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS PRIM PLUMSET-SL PE-LINED

    MDR report key: 9611465 · Received January 21, 2020

    Report

    Report Number
    9615050-2020-00018
    Event Type
    Malfunction
    Date Received
    January 21, 2020
    Date of Event
    December 30, 2019
    Report Date
    December 31, 2019
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887787005315
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE COMPLAINT OF LEAKAGE ON THE 123390488 PRIMARY PLUM SET COULD NOT BE CONFIRMED BY INVESTIGATION. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. THE DHR FOR LOT 4110463 WAS REVIEWED AND NO NON CONFORMANCE WERE FOUND THAT WOULD HAVE LED TO REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE IS NOT AVAILABLE TO RETURN TO THE MANUFACTURER FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A LEAK OF DOXORUBICIN FROM THE CLOSED AIR VENT ON A PLUM SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73506 LS PRIM PLUMSET-SL PE-LINED SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 1233912 4110463 10887787005315

    Patients

    Seq Age Sex Outcome Treatment
    1 DOXORUBICIN, MFR UNK