BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    43 CM (17") APPX 2.8 ML, AMBER TRANSFER SET W/CHEMOCLAVE ADDITIVE PORT, ROTATIN

    MDR report key: 10404731 · Received August 13, 2020

    Report

    Report Number
    9617594-2020-00317
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    August 5, 2020
    Report Date
    August 6, 2020
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    UDI-DI
    00840619095550
    PMA / PMN Number
    K173477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H10: NO PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. HOWEVER, A COMPLAINT HISTORY REVIEW SHOWED THE REPORTED ISSUE OF LEAKAGE AT THE CONNECTION WAS PREVIOUSLY CONFIRMED FOR THE SAME MALE LUER PURCHASED PART LOT NUMBER. THE REPORTED COMPLAINT OF LEAKAGE CAN BE CONFIRMED. THE PROBABLE CAUSE OF THE LEAKAGE IS DUE TO A MOLDING ANOMALY ON THE MALE LUER POST CREATED DURING THE MOLDING PROCESS AT THE SUPPLIERS FACILITY. THE DEVICE HISTORY REVIEW FOR LOT NUMBER 4734811 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DISCARDED. WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. CONCOMITANT PRODUCTS - 28 CM (11") ADD-ON SET W/2 CLAVE®, VENTED CAP, LN 011-H3314, LOT NUMBER 4866115, MFR ICU MEDICAL; PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 272 CM, LN 140019291, LOT NUMBER 4495817, MFR ICU MEDICAL; PLUM 360 PUMP, SN (B)(4), LN 30010-29-13, MFR ICU MEDICAL, OXALIPLATINE/FLUOROURACILE, MFR UNK.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A 43 CM (17") AMBER TRANSFER SET W/CHEMOCLAVE® ADDITIVE PORT, ROTATING LUER, FILTER CAP, 10 UNITS WHERE THERE WAS A LEAK NOTED DURING A CHEMOTHERAPY INFUSION. THE DEVICE WAS CONNECTED TO AN ADD-ON SET AND A PRIMARY PLUMSET AND WAS INFUSING AN UNSPECIFIED CONCENTRATION OF OXALIPLATINE/FLUOROURACILE VIA A PLUM 360 PUMP. A MAJOR LEAK OF CHEMOTHERAPY WAS FOUND TO HAVE LEAKED ON THE FLOOR FROM THE CONNECTION BETWEEN THE TRANSFER SET AND ADD-ON SET AND WAS CLEANED PER PROTOCOL. THERE WAS NO MEDICAL INTERVENTION REQUIRED. ALTHOUGH THERE WAS A DELAY IN THERAPY REPORTED AND AN INCOMPLETE ADMINISTRATION OF THE MEDICATION, THERE WAS NO PATIENT HARM AND NO BLOOD LOSS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867699 43 CM (17") APPX 2.8 ML, AMBER TRANSFER SET W/CHEMOCLAVE ADDITIVE PORT, ROTATIN CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4734811 00840619095550

    Patients

    Seq Age Sex Outcome Treatment
    1 SEE H10