BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE

    MDR report key: 15780745 · Received November 11, 2022

    Report

    Report Number
    9615050-2022-00276
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    October 13, 2022
    Report Date
    October 14, 2022
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    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

    THE DEVICE WAS RECEIVED FOR EVALUATION. THE INVESTIGATION IS STILL PENDING. INITIAL REPORTER PHONE HAS AN EXTENSION NUMBER OF (B)(6).

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED, LIST #123390488, PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE, SECURE LOCK, 103 INCH WITH LOT #5934274 AN ONE USED, LIST #UNKNOWN, BAG SPIKE ADAPTER WITH SPIROS WITH LOT #UNKNOWN. AS RECEIVED THE AIR FILTER ON THE VENT PLUG JUNCTURE WAS WETTED OUT WITH PRIOR INFUSATE. THE PRODUCT WAS TESTED PER PRODUCT SPECIFICATION. THERE WAS A LEAK OBSERVED FROM THE FILTER ON THE VENT PLUG JUNCTURE WITH THE CAP OPEN. THE LEAK APPEARED TO SEEP THROUGH THE FILTER VENT MATERIAL FROM VARIOUS LOCATIONS. THE REPORTED COMPLAINT CAN BE CONFIRMED. THE PROBABLE CAUSE OF LEAKAGE IS DUE TO A TEMPORARY OR COMPLETE LOSS OF HYDROPHOBIC PROPERTIES OF THE FILTER VENT MATERIAL DUE TO AN INFUSATE INTERACTION DURING USE. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PRIMARY PLUM SET THAT WAS REPORTED TO HAVE A LEAKAGE ON FILTER VENT WITH VENT CAP CLOSED DURING INFUSION OF IFOSFAMIDE AND MESNA MEDICATION. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2878092 PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 1233912 5934274

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown IFOSFAMIDE, MFR UNK| MESNA, MFR UNK