BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX

    MDR report key: 21692072 · Received March 25, 2025

    Report

    Report Number
    1314417-2025-00013
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    February 25, 2025
    Report Date
    April 25, 2025
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    CCK
    UDI-DI
    00810071631863
    PMA / PMN Number
    K063813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 25 MAR 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 25 MAR 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. THE COMPLAINT OF "THESE DEVICES HAVE CAUSED A GREAT DEAL OF ISSUES INCLUDING CLINICAL FAILURES ON CARDIAC ARREST EVENTS." REGARDING PART 301-5107ET WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED BUT COULD POSSIBLY BE A RESULT OF USER ERROR. A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE ESCALATION TO THE CAPA REVIEW BOARD. THERE HAVE BEEN 9 OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A "CLINICAL FAILURE" WITH THE ADULT/PED 7FT ETCO2 GAS SAMPLING LINE WITH ET-TUBE ADAPTOR DURING A PATIENT'S CARDIAC ARREST. WANTED TO CLARIFY WHICH INTUBATED CO2 DEVICE IS CAUSING ISSUES FOR THE CREWS. THESE DEVICES HAVE CAUSED A GREAT DEAL OF ISSUES INCLUDING CLINICAL FAILURES ON CARDIAC ARREST EVENTS. I HAVE EVEN HAD OUR MONITOR MANUFACTURER COME OUT AND SERVICE OUR DEVICES THINKING WE HAD AN ISSUE WITH A DEVICE. TO BE CLEAR, THESE ISSUES WE NOT JUST WITH THE CURAPLEX DEVICE BUT ALSO OTHER MANUFACTURER DEVICES. WE HAVE HAD A RUN OF CARDIAC ARRESTS OVER THE PAST MONTHS AND THIS HAS CAUSED A GREAT DEAL OF CONCERNS FROM THE CREWS. OTHER - CROSWELL EMS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A "CLINICAL FAILURE" WITH THE ADULT/PED 7FT ETCO2 GAS SAMPLING LINE WITH ET-TUBE ADAPTOR DURING A PATIENT'S CARDIAC ARREST. WANTED TO CLARIFY WHICH INTUBATED CO2 DEVICE IS CAUSING ISSUES FOR THE CREWS. THESE DEVICES HAVE CAUSED A GREAT DEAL OF ISSUES INCLUDING CLINICAL FAILURES ON CARDIAC ARREST EVENTS. I HAVE EVEN HAD OUR MONITOR MANUFACTURER COME OUT AND SERVICE OUR DEVICES THINKING WE HAD AN ISSUE WITH A DEVICE. TO BE CLEAR, THESE ISSUES WE NOT JUST WITH THE CURAPLEX DEVICE BUT ALSO OTHER MANUFACTURER DEVICES. WE HAVE HAD A RUN OF CARDIAC ARRESTS OVER THE PAST MONTHS AND THIS HAS CAUSED A GREAT DEAL OF CONCERNS FROM THE CREWS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131387 CURAPLEX ADULT 7FT ETCO2 GAS SAMPLING LINE WITH ET-TUBE ADAPTER CCK BOUND TREE MEDICAL, LLC 5107ET 231000212, 240100250 00810071631863

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other