BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS PRIM PLUMSET-SL PE-LINED

    MDR report key: 12984043 · Received December 13, 2021

    Report

    Report Number
    9615050-2021-00178
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 17, 2021
    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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE PHOTO SHOWING INFUSATE RESIDUALS COMING FROM THE VENT PLUG JUNCTURE. THE COMPLAINT OF LEAKAGE CAN BE CONFIRMED ON THE 123390488 BASED ON THE PHOTOS PROVIDED. THERE ARE RESIDUALS OBSERVED INSIDE THE VENT PLUG JUNCTURE WITH THE CAP CLOSED. NO DAMAGE CAN BE OBSERVED FROM THE PHOTO PROVIDED. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. THE DHR FOR LOT 5150019 WAS REVIEWED AND NO NON CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE CUSTOMER PROVIDED A PHOTO, HOWEVER THE INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLUM SET WHERE THE CUSTOMER STATED THERE WAS AN UNSPECIFIED CHEMOTHERAPY SEEPING/LEAKING FROM THE LIGHT-RESISTANT VENT HOLE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1887373 LS PRIM PLUMSET-SL PE-LINED SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 1233912 5150019 10887787005315

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED CHEMOTHERAPY, MFR UNK