BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE

    MDR report key: 9794466 · Received March 5, 2020

    Report

    Report Number
    9615050-2020-00037
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    February 17, 2020
    Report Date
    February 24, 2020
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    20887709101511
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS RETURNED TO THE MANUFACTURER ON MARCH 10, 2020. THE COMPLAINT OF LEAKAGE ON THE RETURNED USED 14007-31 PRIMARY PLUM SET COULD BE CONFIRMED. THE PRODUCT WAS TESTED PER PRODUCT SPECIFICATION. THERE WAS A LEAK FROM VENT PLUG JUNCTURE WITH THE CAP OPENED. THE LEAK APPEARED TO SEEP THROUGH THE FILTER VENT MATERIAL FROM VARIOUS LOCATIONS. 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 REACTION DURING USE. A DHR LOT# 4180024 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO RETURN TO THE MANUFACTURER FOR INVESTIGATION; IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A PLUM SET THAT LEAKED THROUGH THE FILTER VENT COVER FROM THE DRIP CHAMBER. THE MEDICATION INVOLVED WAS CARBOPLATIN AT A RATE OF 500ML/HR. THE EVENT OCCURRED DURING PATIENT USE, THERE WAS A DELAY IN THERAPY, HOWEVER, NO ONE WAS HARMED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258691 PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 4180024 20887709101511

    Patients

    Seq Age Sex Outcome Treatment
    1 CARBOPLATIN, UNK MFR