BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX

    MDR report key: 18377722 · Received December 21, 2023

    Report

    Report Number
    1314417-2023-00030
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 29, 2023
    Report Date
    July 12, 2024
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    BTM
    UDI-DI
    00812277037029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISK ON THE BOTTOM THAT ACTS AS A ONE-WAY VALVE CAME LOOSE AND WAS FOUND IN THE BAG. THIS CAUSED A LACK OF POSITIVE PRESSURE RESULTING IN A DELAY OF RESUSCITATION EFFORTS FOR THE PATIENT. THE PATIENT IS IN CRITICAL CARE ON A VENTILATOR CURRENTLY. THE FAILURE WAS NOTED QUICKLY, AND A REPLACEMENT WAS USED FROM A BACKUP ON THE AMBULANCE.

    Additional Manufacturer Narrative · 0

    THE DISK ON THE BOTTOM THAT ACTS AS A ONE-WAY VALVE CAME LOOSE AND WAS FOUND IN THE BAG. THIS CAUSED A LACK OF POSITIVE PRESSURE RESULTING IN A DELAY OF RESUSCITATION EFFORTS FOR THE PATIENT. THE PATIENT IS IN CRITICAL CARE ON A VENTILATOR CURRENTLY. THE FAILURE WAS NOTED QUICKLY, AND A REPLACEMENT WAS USED FROM A BACKUP ON THE AMBULANCE. **UDI RELATED DATA QUALITY UPDATES** IN ADDITION, INVESTIGATION WAS COMPLETED WITH THE FOLLOWING UPDATES: THE COMPLAINT OF "THE DISK ON THE BOTTOM THAT ACTS AS A ONE-WAY VALVE CAME LOOSE AND WAS FOUND IN THE BAG." REGARDING PART NUMBER 2442-BVMPSA/LOT 363395 WAS NOT CONFIRMED AS THERE WAS NO RETURNED PRODUCT, PICTURES OR VIDEO TO EVALUATE. THIS COMPLAINT COULD POTENTIALLY BE RELATED TO A LOOSE DIAPHRAGM VALVE WITHIN THE BAG BODY THAT WAS NOT ASSEMBLED CORRECTLY AND BECAME LOOSE PRIOR TO END-USE. THE DEVICE HISTORY RECORD (DHR) REVIEW SHOWED NO ABNORMAL PROCESSING ISSUES NOTED RELATED TO THIS COMPLAINT; THE TAIL VALVE ASSEMBLY (PN 3010007) WAS FROM LOT NUMBERS 220700087 AND 220600023, AND THOSE LOTS PASSED INSPECTION. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE HIGH WHICH DOES REQUIRE REPORTING TO THE CAPA REVIEW BOARD; THE COMPLAINT WAS SUBMITTED TO CARB. THERE HAVE BEEN ZERO (0) OTHER COMPLAINTS REGARDING PART NUMBER 2442-BVMPSA FOR THE SAME ISSUE WITHIN THE 24 MONTHS PRECEDING THE REPORTING OF THIS ISSUE. A MEMO, CONTAINING THE COMPLAINT INVESTIGATION, WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

    Description of Event or Problem · 0

    THE DISK ON THE BOTTOM THAT ACTS AS A ONE-WAY VALVE CAME LOOSE AND WAS FOUND IN THE BAG. FAILURE WAS ON AN AMBULANCE. THE UNIT FAILURE RESULTED IN LACK OF POSITIVE PRESSURE. THE AIRWAY EMT NOTICED THIS AND CHANGED TO ANOTHER UNIT THAT IN FACT OPERATED CORRECTLY. THE ETCO2 IMPROVEMENT WAS DRAMATIC.

    Description of Event or Problem · 0

    THE DISK ON THE BOTTOM THAT ACTS AS A ONE-WAY VALVE CAME LOOSE AND WAS FOUND IN THE BAG. FAILURE WAS ON AN AMBULANCE. THE UNIT FAILURE RESULTED IN LACK OF POSITIVE PRESSURE. THE AIRWAY EMT NOTICED THIS AND CHANGED TO ANOTHER UNIT THAT IN FACT OPERATED CORRECTLY. THE ETCO2 IMPROVEMENT WAS DRAMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277783 CURAPLEX CURAPLEX SMALL ADULT/PEDIATRIC PREMIUM BVM W/ BAG RESERVOIR, MANOMETER, 25CM POP BTM BOUND TREE MEDICAL, LLC AF2000 363395 00812277037029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other