BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNMED LLC

    MDR report key: 19148726 · Received April 19, 2024

    Report

    Report Number
    1314417-2024-00020
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    February 21, 2024
    Report Date
    April 19, 2024
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    BYD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENTS SECRETIONS GOING STRAIGHT INTO THE FILTER WOULD CAUSE A DISRUPTION OF THERAPY. THE CLINICIANS INABILITY TO SUCTION THE SEXRETIONS WOULD CAUSE A BLOCKAGE AND CHOCKING HAZARD FOR THE PATIENT. THIS WOULD CAUSE THE PATIENT'S OXYGEN LEVELS TO DECREASE AND DELAY PROPER VENTILATION THE COMPLAINT OF "AIR LEAKING DURING INTUBATION, NOT DELIVERING THE PATIENT O2." REGARDING PART NUMBER AF5140MB/LOT 428861 WAS CONFIRMED. RETURNED PRODUCT WAS INVESTIGATED. VISUAL INSPECTION IDENTIFIED A LOOSE DIAPHRAGM VALVE WITHIN THE BAG BODY AND IT WAS CONCLUDED THAT THE DIAPHRAGM VALVE WAS NOT ASSEMBLED CORRECTLY AND BECAME LOOSE PRIOR TO END-USE. 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 AND THEY DECIDED TO OPEN A CAPA ((B)(4)) FOR THIS ISSUE. THERE HAVE BEEN TWO (2) OTHER CONFIRMED COMPLAINTS REGARDING PART NUMBER AF5140MB 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.

    Additional Manufacturer Narrative · 0

    THE PATIENTS SECRETIONS GOING STRAIGHT INTO THE FILTER WOULD CAUSE A DISRUPTION OF THERAPY. THE CLINICIANS INABILITY TO SUCTION THE SECRETIONS WOULD CAUSE A BLOCKAGE AND CHOCKING HAZARD FOR THE PATIENT. THIS WOULD CAUSE THE PATIENT'S OXYGEN LEVELS TO DECREASE AND DELAY PROPER VENTILATION.

    Description of Event or Problem · 0

    PATIENT'S SECRETIONS WENT STRAIGHT THROUGH HME AND INTO VENTILATOR CIRCUIT.  WHILE BEING SUCTIONED, SMALL AMOUNT OF SECRETIONS WENT THRU THE HME AND VENTILATOR CIRCUIT. PATIENT NOT ABLE TO MOVE VOLUMES AND BREATHE ON THE VENTILATOR .

    Description of Event or Problem · 0

    PATIENT'S SECRETIONS WENT STRAIGHT THROUGH HME AND INTO VENTILATOR CIRCUIT.  WHILE BEING SUCTIONED, SMALL AMOUNT OF SECRETIONS WENT THRU THE HME AND VENTILATOR CIRCUIT. PATIENT NOT ABLE TO MOVE VOLUMES AND BREATHE ON THE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824276 SUNMED LLC BYPASS HME BYD SUNMED HOLDINGS LLC DYNJAABHME UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other