BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    46 CM (18") PUR TRANSFER SET W/CHEMOLOCK¿ ADDITIVE PORT, CHECK VALVE W/LUER LOCK

    MDR report key: 19283208 · Received May 9, 2024

    Report

    Report Number
    9617594-2024-00575
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 1, 2024
    Report Date
    June 22, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    UDI-DI
    00840619092658
    PMA / PMN Number
    K131549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AS THE CUSTOMER HAS DISCARDED IT. WITHOUT THE RETURN OF THE DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF NO FLOW COULD NOT BE CONFIRMED FROM THE PHOTO PROVIDED, THE RETURNED PHOTO SHOWS AN UNKNOWN NON-ICU MEDICAL PRODUCT. WITHOUT THE RETURN OF THE AFFECTED ICU MEDICAL SAMPLE, AN INVESTIGATION CANNOT BE PERFORMED AND A PROBABLE CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ON AN UNKNOWN DATE, 46 CM (18") PUR TRANSFER SET W/CHEMOLOCK¿ ADDITIVE PORT, CHECK VALVE W/LUER LOCK, FILTER CAP GENERATED A NO FLOW EVENT DURING USE WITH A PATIENT. THE REPORTER STATED THAT, THAT THEY CANNOT PERFORM INFUSION OF NAB-PACLITAXEL AS THE SOLUTION DOES NOT PASS THE EXTENSION LINE AND PATIENT DOES NOT RECEIVE THE DESIRED DOSE, IT EITHER STOPS DRIPPING THROUGH THE EXTENSION LINE, OR THEY NEED TO PRIME THE LINE AGAIN A FEW TIMES, BUT IT ALSO MIGHT NOT HELP. THEY HAD NO SUCH PROBLEM WITH PHASEAL AND NOW ARE FORCED TO USE PHASEAL SYSTEMS IN CASE OF NAB-PACLITAXEL INFUSIONS. THE REPORTER STATED THAT "AFTER SWITCHING TO THE NEW LINES (WHICH ARE ATTACHED TO THE CHEMOTHERAPY BOTTLE) IT WAS NO LONGER POSSIBLE TO COMPLETE THE INFUSION OF THE CHEMOTHERAPY DRUG NAB-PACLITAXEL (ABRAXANE). EVERY TIME, ABOUT HALFWAY THROUGH THE INFUSION (10-15 MIN BEFORE THE END), THE INFUSER STARTS TO GIVE AN ALARM "CHECK UPSTREAM" AND DOES NOT ALLOW THE DRUG TO DRIP ANY FURTHER. HOWEVER, THE INTERMEDIATE CONTAINER HAS BEEN FILLED, THE CANNULA INSTALLED ON THE PATIENT HAS WORKED, THE LINE BETWEEN THE MACHINE HAS DRAWN INTO THE VACUUM AND REMAINS IN THE VACUUM, THE LINE HAS BEEN REMOVED FROM THE INFUSER AND AN ATTEMPT HAS BEEN MADE TO CONTINUE ADMINISTERING THE MEDICINE WITH SO-CALLED FREE FLOW, WHICH USUALLY WORKS BUT NOT WHEN ADMINISTERING THIS DRUG (NAB-PACLITAXEL). THE NURSES WHO ADMINISTER THE MEDICINE HAVE TRIED ALL POSSIBLE OPTIONS SO THAT THE MEDICINE CAN BE ADMINISTERED UNTIL THE END, BUT NOTHING WORKED. THE NURSES THEN ASKED THE PHARMACY TO ORDER PHASEAL CLOSED SYSTEM TRANSFER DEVICE (CSTD) INSTEAD." A PHOTO WAS PROVIDED SHOWING THE AFFECTED PRODUCT. THE STATUS OF THE PRODUCT AT THE TIME OF EVENT WAS CONNECTED TO INFUSION TUBING. THE PRODUCT WAS STORED IN THE FACILITY ACCORDING TO RULES, ROOM TEMPERATURE AND DRY ROOM. NO CUTS, HOLES OR DEFECTS NOTED ON THE PRODUCT. NO UNPROTECTED CHEMO EXPOSURE. IT DID NOT COME INTO CONTACT WITH THE PATIENT OR HEALTH CARE PROVIDER. THE SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. NO PATIENT HARM WAS NOTED; THE PATIENT DID NOT RECEIVE THE WHOLE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100191 46 CM (18") PUR TRANSFER SET W/CHEMOLOCK¿ ADDITIVE PORT, CHECK VALVE W/LUER LOCK CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13528333 00840619092658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NAB-PACLITAXEL, UKN MFR.| PHASEAL, UNK MFR.