BEUDAMED
    FDA Adverse Event Injury Summary report: N

    30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHA

    MDR report key: 18297954 · Received December 8, 2023

    Report

    Report Number
    9617594-2023-01109
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    November 7, 2023
    Report Date
    February 16, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    PMA / PMN Number
    K131549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COUPLE OF PHOTOS WERE SHARED BY CUSTOMER. THE SET IS CONNECTED WITH AN UNKNOWN RED SOLUTION AND THERE IS OBSERVED HOW THE CLAMP IS ON ACTIVATED POSITION AND A LITTLE RED COLOR IS OBSERVED BEYOND THE CLAMP, HOWEVER THERE IS NO FLUID OVER THE LINE. NO ADDITIONAL LEAKS OR ANOMALIES ARE OBSERVED ON THE PHOTOS. THE COMPLAINT OF LEAKS CANNOT BE CONFIRMED BASED ON THE PHOTOS PROVIDED BY THE CUSTOMER, WHERE A LITTLE RED COLOR IS OBSERVED BEYOND THE CLAMP, HOWEVER THERE IS NO FLUID OVER THE LINE. WITHOUT THE RETURN OF THE PRODUCT SAMPLE, AN INVESTIGATION AND A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, THEREFORE A PROBABLE CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REVIEW OF LOT#8983798 WAS REVIEWED AND NO NON CONFORMITIES WERE FOUND THAT WOULD HAVE LED THE REPORTED CONDITION ON THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    ONE (1) USED SAMPLE LIST #CL3528, CONNECTED INTO AN UNKNOWN 500ML BAG WAS RETURNED FOR EVALUATION. AS RECEIVED A WETTED-OUT CONDITION WAS OBSERVED ON THE OUTLET FILTER VENT, NO ADDITIONAL DAMAGE OR ANOMALIES WERE OBSERVED. THE SET WAS TESTED AS PER PROCEDURE AND A LEAK COMING FROM THE OUTLET FILTER VENT WAS CONFIRMED, NO ADDITIONAL LEAKS ALONG THE DEVICE WERE OBSERVED. COMPLAINTS OF LEAKS CAN BE CONFIRMED BASED ON THE USED PHYSICAL SAMPLE EVALUATION. THE PROBABLE CAUSE IS TYPICALLY DUE TO A TEMPORARY OR COMPLETE LOSS OF HYDROPHOBIC PROPERTIES OF THE FILTER VENT MATERIAL DUE TO AN INFUSATE INTERACTION DURING USE. D9 - DATE RETURNED TO MFG: 1/9/2024.

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. WITHOUT THE RETURNED DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHAMBER, 0.2 MICRON FILTER, CHEMOLOCK¿ W/RED CAP, HANGER GENERATED A LEAK. IT WAS REPORTED THAT THEY HAD A LEAK ISSUE, AN ONCOLOGY NURSE MIO REPORTED THAT THERE WAS A LEAK FROM HER INFUSION BAG. THE PATIENT RECEIVED THE FULL DOSE AND AFTER THE CHEMO INFUSION WAS COMPLETED, THE NURSE WAS CLEANING UP THE ETOPOSIDE/DOXO/VCR BAG AND NOTICED TWO DROPS OF RED CHEMO UNDER THE FILTER. A TRACE OF CHEMO-LIKE FLUID WAS FOUND BELOW THE FILTER ON TOP OF THE IV PUMP. THE SPILL WAS CLEANED UP ACCORDING TO THE SPILL POLICY. THIS WAS A 24-HOUR INFUSION. AT LEAST 3 REGISTERED NURSES RNS WITNESSED THAT THERE WERE 2 DROPS OF CHEMO FLUID UNDERNEATH THE FILTER AND THERE WAS ONLY 1 AFFECTED BAG. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326888 30" (76CM) APPX 6.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP CHA CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8983798

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown