BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET, 2 CLAVE MULTIPORT CONNECTOR, BALL CHECK VALVE IN SIGHT CHAMBER

    MDR report key: 9973742 · Received April 17, 2020

    Report

    Report Number
    9615050-2020-00056
    Event Type
    Malfunction
    Date Received
    April 17, 2020
    Date of Event
    March 25, 2020
    Report Date
    March 31, 2020
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K982159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10 - THE COMPLAINT OF LEAKAGE CAN BE CONFIRMED ON THE RETURNED ONE USED 121933190 PRIMARY PLUM SET. THE SECONDARY PORT WAS BENT AND THERE WAS A BREAK OBSERVED ON THE CASSETTE AS RECEIVED. THERE WAS PLASTIC DEFORMATION OBSERVED ON THE SECONDARY PORT. THE SET LEAKED FROM THE BREAK OBSERVED. THE PROBABLE CAUSE OF THE DAMAGE OBSERVED IS UNKNOWN HOWEVER, IT WOULD HAVE HAPPENED OUTSIDE ICU MEDICAL. A DEVICE HISTORY REVIEW FOR LOT# 4040976 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION CAN BE FOUND IN SECTION G1.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO RETURN FOR EVALUATION. IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A PRIMARY PLUMSET THAT DURING CHEMOTHERAPY TREATMENT A LEAK WAS OBSERVED. THE PATIENT WAS RECEIVING THE 5 CYCLE OF POLY-CHEMOTHERAPY APPLICATION, DAY 15 OF THE FLOT PROTOCOL (DOCETAXEL + CALCIUM FOLINATE IN OXALIPLATIN, 5 FLUOROURACIL IN INFUSER). AT 14 O¿CLOCK, WHEN THE MIXTURE OF OXALIPLATIN IN CALCIUM FOLINATE WAS ALREADY INFUSING, A LEAK WAS OBSERVED FROM THE SET LINE B, WHERE THE CALCIUM FOLINATE WAS CONNECTED. THE INFUSION WAS STOPPED, THE SET WAS CHECKED, AND IT WAS NOTED THAT THE SET WAS BROKEN IN THE LINE B, CONNECTOR. THE TUBING SET WAS REPLACED. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO HARMED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435887 PRIMARY PLUM SET, 2 CLAVE MULTIPORT CONNECTOR, BALL CHECK VALVE IN SIGHT CHAMBER SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 4040976

    Patients

    Seq Age Sex Outcome Treatment
    1 5 FLUOROURACIL, MFR UNK| CALCIUM FOLINATE, MFR UNK| DOCETAXEL, MFR UNK| OXALIPLATIN, MFR UNK