BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    QUANTUM PERFUSION DUAL LUMEN CANNULA 31F

    MDR report key: 13575707 · Received February 22, 2022

    Report

    Report Number
    3016746283-2022-00001
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    February 12, 2022
    Report Date
    February 12, 2022
    Manufacturer
    QURA S.R.L
    Product Code
    DWF
    UDI-DI
    08051160300792
    PMA / PMN Number
    K203067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW-UP COMMUNICATION WITH THE HOSPITAL, THE BEDSIDE SPECIALIST NOTICED A SMALL AMOUNT OF AIR ENTRAINMENT IN THE CIRCUIT. THEY CHECKED THE CIRCUIT AND CRRT CIRCUIT FOR LEAKS AND FOUND NOTHING. THEY TOOK THE CRRT CIRCUIT AWAY AND IT WAS STILL ENTRAINING AIR. AFTER THAT THEY CHANGED OUT THE ENTIRE CIRCUIT. SOON AFTER, THEY TURNED THE PATIENT TO CLEAN HIM. AT THAT POINT, THE ENTIRE CIRCUIT FILLED WITH AIR. THE PATIENT WAS CODED FOR ABOUT 45 MINUTES AND EMERGENTLY CONVERTED TO FEM - FEM VA ECMO. AFTER EXAMINING THE CANNULA THEY DISCOVERED THAT IT DECOUPLED AT THE BIFURCATION. THIS PATIENT WAS DOING SOME DAILY PT, SITTING UP ON THE SIDE OF THE BED, AND ATTEMPTING TO STAND SOME. YOU WILL NOTICE IN THE PICTURE BELOW THAT THEY HAVE FOAM PADS ON THE TUBING. THAT WAS TO PROTECT THE PATIENT'S EARS FROM RUBBING. THE MANUFACTURER INVESTIGATION REPRODUCED THE EVENT IN THE LABORATORY. IT IS A HIGH PROBABILITY THAT THE ROOT CAUSE COULD BE IDENTIFIED AS "CHLORAPREP APPLICATOR THAT CONTAINS 70% ISOPROPANOL" TO CLEAN THE INSERTION AREA OF THE CANNULA AND SKIN MULTIPLE TIMES OVER 16 DAYS WITH AN ACCIDENTAL EXPOSURE TO THE BONDING OF THE DRAINAGE LUMEN AND Y HUB CONNECTOR. THE PATIENT IS ALERT AND RESPONDING TO COMMANDS.

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW-UP COMMUNICATION WITH THE HOSPITAL, THE BEDSIDE SPECIALIST NOTICED A SMALL AMOUNT OF AIR ENTRAINMENT IN THE CIRCUIT. THEY CHECKED THE CIRCUIT AND CRRT CIRCUIT FOR LEAKS AND FOUND NOTHING. THEY TOOK THE CRRT CIRCUIT AWAY AND IT WAS STILL ENTRAINING AIR. AFTER THAT THEY CHANGED OUT THE ENTIRE CIRCUIT. SOON AFTER, THEY TURNED THE PATIENT TO CLEAN HIM. AT THAT POINT, THE ENTIRE CIRCUIT FILLED WITH AIR. THE PATIENT WAS CODED FOR ABOUT 45 MINUTES AND EMERGENTLY CONVERTED TO FEM - FEM VA ECMO. AFTER EXAMINING THE CANNULA THEY DISCOVERED THAT IT DECOUPLED AT THE BIFURCATION. THIS PATIENT WAS DOING SOME DAILY PT, SITTING UP ON THE SIDE OF THE BED, AND ATTEMPTING TO STAND SOME. YOU WILL NOTICE IN THE PICTURE BELOW THAT THEY HAVE FOAM PADS ON THE TUBING. THAT WAS TO PROTECT THE PATIENT'S EARS FROM RUBBING. THE MANUFACTURER INVESTIGATION REPRODUCED THE EVENT IN THE LABORATORY. IT IS A HIGH PROBABILITY THAT THE ROOT CAUSE COULD BE IDENTIFIED AS "CHLORAPREP APPLICATOR THAT CONTAINS 70% ISOPROPANOL" TO CLEAN THE INSERTION AREA OF THE CANNULA AND SKIN MULTIPLE TIMES OVER 16 DAYS WITH AN ACCIDENTAL EXPOSURE TO THE BONDING OF THE DRAINAGE LUMEN AND Y HUB CONNECTOR. THE PATIENT IS ALERT AND RESPONDING TO COMMANDS.

    Description of Event or Problem · 0

    31FR QUANTUM DUAL LUMEN CANNULA WAS IN PLACE ON A PATIENT PROVIDING SUPPORT. THE CANNULA BECAME DECOUPLED OUTSIDE OF THE PATIENT, NEAR THE "METAL FINGERS" WHERE THE WIRE REINFORCEMENT AREA STOPS. THE PATIENT WAS RESUSCITATED ON VA ECMO SUPPORT AND PHYISCIAN REPORTED THAT THE PATIENT APPEARS TO BE INTACT. HOSPITAL IS PERFORMING INTERNAL RISK MANAGEMENT PROCESS, THEN THE DEVICE WOULD BE AVAILABLE FOR CUSTOMER RETURN.

    Description of Event or Problem · 0

    31FR QUANTUM DUAL LUMEN CANNULA WAS IN PLACE ON A PATIENT PROVIDING SUPPORT. THE CANNULA BECAME DECOUPLED OUTSIDE OF THE PATIENT, NEAR THE "METAL FINGERS" WHERE THE WIRE REINFORCEMENT AREA STOPS. THE PATIENT WAS RESUSCITATED ON VA ECMO SUPPORT AND PHYISCIAN REPORTED THAT THE PATIENT APPEARS TO BE INTACT. HOSPITAL IS PERFORMING INTERNAL RISK MANAGEMENT PROCESS, THEN THE DEVICE WOULD BE AVAILABLE FOR CUSTOMER RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005634 QUANTUM PERFUSION DUAL LUMEN CANNULA 31F DUAL LUMEN CANNULA 31F DWF QURA S.R.L DL31F-V0 D002352 08051160300792

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Life Threatening| R