BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMOLOCK¿

    MDR report key: 16335455 · Received February 9, 2023

    Report

    Report Number
    9617594-2023-00073
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    January 12, 2023
    Report Date
    January 12, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    UDI-DI
    00887709056992
    PMA / PMN Number
    K131549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED. LIST #CL2000S, CHEMOLOCK¿; LOT #7880780. RECEIVED ONE USED. MANUFACTURER UNKNOWN, INFUSION SET; LOT #UNKNOWN. TAXOL, PACLITAXEL RESIDUALS OBSERVED IN RECEIVED TWO USED WITH LIST #CL2000S AND MATING DEVICE. THE COMPLAINT OF DISCONNECTION CAN BE CONFIRMED. AS RECEIVED THE SPIN FEATURE OF EACH CHEMOLOCK WAS ACTIVATED AND SPINNING FREELY. ONE OF THE CHEMOLOCK WAS ATTACHED TO AN UNKNOWN; HOWEVER, THE FEMALE LUER WAS OBSERVED TO BE ON LOOSE ON THE MALE LUER. IT IS UNKNOWN IF THE CHEMOLOCK WAS RE-ATTACHED AFTER DISCONNECTION. THERE WERE NO DAMAGES OR ANOMALIES OBSERVED. THERE WAS NO SPLINE DAMAGE. THERE WAS NO DAMAGE OBSERVED ON THE MALE LUER THREADS OF THE MATING DEVICE. THERE WAS NO DAMAGE OBSERVED ON THE FEMALE LUER THREADS. EACH CHEMOLOCK EXHIBITED UNRESTRICTED SPIN FEATURE ROTATION. THE SAMPLES SHOWED NO EVIDENCE OF A SHEAR TAB MALFUNCTION. THE MEASURED TORQUE VALUES OF THE CHEMOLOCKS MET PRODUCT PERFORMANCE SPECIFICATIONS AND WOULD NOT RESULT IN A DISCONNECTION. THE PROBABLE CAUSE OF THE DISCONNECTION IS UNKNOWN. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. THE INVESTIGATION IS NOT YET COMPLETE.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A CHEMOLOCK¿ INJECTOR THAT HAD A CHEMOTHERAPY, PACLITAXEL (TAXOL), SPILL DURING INFUSION, AND IT CAME IN CONTACT WITH THE PATIENT. IT WAS REPORTED THAT THE CLEAR PLASTIC PART OF THE CHEMOLOCK THAT CONNECTS TO THE IV TUBING, BECAME UNATTACHED AND THAT THE TUBING CAN UNSCREW FROM THE CHEMOLOCK. FURTHERMORE, IT WAS NOT A USER ERROR AS THEY WERE ABLE TO REPLICATE IT 4 TIMES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED, AND NO MEDICAL INTERVENTIONS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607737 CHEMOLOCK¿ CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CL2000S 7880780 00887709056992

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PACLITAXEL (TAXOL), MFR UNK| UNSPECIFIED IV TUBING, MFR UNK