BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX

    MDR report key: 18326718 · Received December 14, 2023

    Report

    Report Number
    1314417-2023-00029
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 2, 2023
    Report Date
    July 23, 2024
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    BYE
    UDI-DI
    00810071637278
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESUSCITATION BAG WAS BEING USED WITH THE PEEP VALVE THAT COULD HAVE BEEN BLOCKED, WHICH WOULD HAVE DELAYED TREATMENT. THE COMPLAINT OF "PEEP VALVE NOT MAKING STANDARD NOISE. PT NOT FULLY EXHALING." REGARDING PART 301-MRIPEEP-A WAS NOT CONFIRMED BECAUSE FUNCTIONAL TESTING INDICATED THAT THE DEVICE FORMED AS INTENDED. THE ROOT CAUSE CANNOT BE DETERMINED BUT COULD POSSIBLY BE A RESULT OF AN ISSUE WITH THE RESUS BAG THAT WAS USED. A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE THE INITIATION OF A CAPA. THERE HAVE BEEN NO OTHER COMPLAINTS AGAINST THIS PART IN THE 24 MONTHS PRECEDING THIS COMPLAINT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. **UDI RELATED DATA QUALITY UPDATES ONLY.**

    Additional Manufacturer Narrative · 0

    THE RESUSCITATION BAG WAS BEING USED WITH THE PEEP VALVE THAT COULD HAVE BEEN BLOCKED, WHICH WOULD HAVE DELAYED TREATMENT.

    Additional Manufacturer Narrative · 0

    THE RESUSCITATION BAG WAS BEING USED WITH THE PEEP VALVE THAT COULD HAVE BEEN BLOCKED, WHICH WOULD HAVE DELAYED TREATMENT. THE COMPLAINT OF "PEEP VALVE NOT MAKING STANDARD NOISE. PT NOT FULLY EXHALING." REGARDING PART 301-MRIPEEP-A WAS NOT CONFIRMED BECAUSE FUNCTIONAL TESTING INDICATED THAT THE DEVICE FORMED AS INTENDED. THE ROOT CAUSE CANNOT BE DETERMINED BUT COULD POSSIBLY BE A RESULT OF AN ISSUE WITH THE RESUS BAG THAT WAS USED. A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE THE INITIATION OF A CAPA. THERE HAVE BEEN NO OTHER COMPLAINTS AGAINST THIS PART IN THE 24 MONTHS PRECEDING THIS COMPLAINT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 0

    UPON DISCONNECTING PT FROM VENT AND MANUALLY BAGGING TO ICU. WITHIN FIRST COUPLE BREATHS MANUALLY DELIVERED, NOTICED PEEP VALVE WAS NOT MAKING STANDARD NOISE. UPON FURTHER ASSESSMENT NOTICE PTS CHEST KEPT RISING BUT NOT FALLING. QUICKLY DISCONNECTED FROM ET TUBE AND NOTED A HUGE RUSH OF AIR RELEASED FROM ET TUBE. ONE MORE TIME I RECONNECTED BAG AND DELIVERED TWO MORE BREATHS NOTING AGAIN NO TRUE EXHALE FROM PT/BAG. DISCONNECTED AGAIN AND RUSH OF AIR NOTED AGAIN. QUICKLY HAD PT RETURNED TO ROOM AND PLACED BACK ON VENT. ACQUIRED NEW AMBU BAG AND PEEP VALVE. NEW EQUIPMENT WORKED PROPERLY AND PT WAS SAFELY DELIVERED TO NEW UNIT.

    Description of Event or Problem · 0

    UPON DISCONNECTING PT FROM VENT AND MANUALLY BAGGING TO ICU. WITHIN FIRST COUPLE BREATHS MANUALLY DELIVERED, NOTICED PEEP VALVE WAS NOT MAKING STANDARD NOISE. UPON FURTHER ASSESSMENT NOTICE PTS CHEST KEPT RISING BUT NOT FALLING. QUICKLY DISCONNECTED FROM ET TUBE AND NOTED A HUGE RUSH OF AIR RELEASED FROM ET TUBE. ONE MORE TIME I RECONNECTED BAG AND DELIVERED TWO MORE BREATHS NOTING AGAIN NO TRUE EXHALE FROM PT/BAG. DISCONNECTED AGAIN AND RUSH OF AIR NOTED AGAIN. QUICKLY HAD PT RETURNED TO ROOM AND PLACED BACK ON VENT. ACQUIRED NEW AMBU BAG AND PEEP VALVE. NEW EQUIPMENT WORKED PROPERLY AND PT WAS SAFELY DELIVERED TO NEW UNIT.

    Description of Event or Problem · 0

    UPON DISCONNECTING PT FROM VENT AND MANUALLY BAGGING TO ICU. WITHIN FIRST COUPLE BREATHS MANUALLY DELIVERED, NOTICED PEEP VALVE WAS NOT MAKING STANDARD NOISE. UPON FURTHER ASSESSMENT NOTICE PTS CHEST KEPT RISING BUT NOT FALLING. QUICKLY DISCONNECTED FROM ET TUBE AND NOTED A HUGE RUSH OF AIR RELEASED FROM ET TUBE. ONE MORE TIME I RECONNECTED BAG AND DELIVERED TWO MORE BREATHS NOTING AGAIN NO TRUE EXHALE FROM PT/BAG. DISCONNECTED AGAIN AND RUSH OF AIR NOTED AGAIN. QUICKLY HAD PT RETURNED TO ROOM AND PLACED BACK ON VENT. ACQUIRED NEW AMBU BAG AND PEEP VALVE. NEW EQUIPMENT WORKED PROPERLY AND PT WAS SAFELY DELIVERED TO NEW UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779750 CURAPLEX PEEP VALVE,19MM,MRI,30MM ADAPTER 20/ CA CLOSE BYE BOUND TREE MEDICAL, LLC MRIPEEP-A UNKNOWN 00810071637278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other