BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE CLEAR, CHEMOLOCK PORT, SPIROS

    MDR report key: 11751932 · Received April 30, 2021

    Report

    Report Number
    9617594-2021-00143
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 5, 2021
    Report Date
    April 5, 2021
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    UDI-DI
    00887709077201
    PMA / PMN Number
    K131549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED LIST # CL3931, 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE¿ CLEAR, CHEMOLOCK¿ PORT, SPIROS¿ W/RED CAP, CLAMP; (LOT #5000397) WAS RECEIVED FOR EVALUATION AND VISUALLY INSPECTED. AS RECEIVED, AXIAL CRACKS WERE OBSERVED ON THE EXTERIOR OF THE MALE LUER COLLAR OF THE BONDED MALE LUER ADAPTOR/SPIROS SUBASSEMBLY. AXIAL CRACKS WERE ALSO PRESENT ON THE FEMALE LUER OF THE BONDED SPIROS. NO ADDITIONAL DAMAGE OR ANOMALIES WERE IDENTIFIED. NO MATING DEVICES WERE RETURNED. A FUNCTIONAL TEST WAS PERFORMED; THE RETURNED SET WAS PRIMED WITH WATER AT GRAVITY PRESSURE AND THEN LEAK TESTED PER PROCEDURE. SLIGHT FLUID ACCUMULATION OCCURRED IN BETWEEN THE LUER THREADS OF THE BONDED SPIROS AND MALE LUER ADAPTOR WAS OBSERVED. NO OTHER LEAKAGE WAS SEEN FROM THE SET. A PHOTO WAS PROVIDED AND EVALUATED. THE PHOTO SHOWS ONE EXTENSION SET IN A PLASTIC BIOHAZARD BAG. NO VISIBLE DAMAGE OR ANOMALIES CAN BE SEEN IN THE IMAGE. A LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE REPORTED COMPLAINT OF LEAKAGE CAN BE CONFIRMED. THE PROBABLE CAUSE OF THE CRACKS ON THE SPIROS FEMALE LUER AND THE BONDED MALE LUER ADAPTOR IS LIKELY DUE TO UNKNOWN EXTERNAL IMPACT FORCE.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE® CLEAR, CHEMOLOCK¿ PORT, SPIROS® W/RED CAP, CLAMP. IT WAS REPORTED THAT ON THE PATIENT¿S 5TH, AND LAST, DAY OF R-EPOCH THE DEVICE WAS LEAKING FROM THE SPIROS END ONTO THE PATIENT'S BED. THE CHEMOTHERAPY INFUSING WAS DOXORUBICIN, ETOPOSIDE AND VINCRISTINE. THE PATIENT, AND AREA, WERE CLEANED UP PER THE CUSTOMER'S PROTOCOL. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THE SPIROS WAS CONNECTED TO THE BAXTER ONELINK ON PATIENT'S PORTAL. THERAPY WAS ENDED; THERE WAS NO BLOOD LOSS OR BLEED BACK. NO HOLES WERE NOTED ON THE DEVICE. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO ADVERSE EVENT OR HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651921 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE CLEAR, CHEMOLOCK PORT, SPIROS CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CL3931 5000397 00887709077201

    Patients

    Seq Age Sex Outcome Treatment
    1