BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUCHOICE

    MDR report key: 2329957 · Received July 20, 2011

    Report

    Report Number
    3004986960-2011-00001
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ALLIANT HEALTHCARE PRODUCTS
    Product Code
    MJJ
    PMA / PMN Number
    K001245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY'S INITIAL INVESTIGATION OF THE ACTUAL DEVICE THAT CAUSED THE COMPLAINT INDICATES THAT THE GLUE BOND WAS NOT SUFFICIENT. PRIOR TO (B)(4) 2011, THERE HAVE BEEN NO OTHER REPORTED PRODUCT MALFUNCTIONS SINCE THE COMPANY STARTED PRODUCING THE PRODUCT 5 YEARS AGO. THE COMPANY HAS PRODUCED APPROX (B)(4) VENT VALVE DEVICES DURING THE SAME PERIOD. THE COMPANY HAS TAKEN THE FOLLOW ACTIONS: IMMEDIATELY UPON NOTIFICATION OF THE COMPLAINT ON (B)(4), THE COMPANY FORMED A REVIEW TEAM TO INVESTIGATE THE HEALTH RISK TO PTS AND ROOT CAUSE. THE COMPANY'S INVESTIGATION IS ON-GOING AND NO DEFINITIVE ROOT CAUSE HAS BEEN IDENTIFIED. THERE IS NO SPECIFIC INFO THAT LEADS TO ANY FINAL CONCLUSION AT THIS TIME. CORRECTIVE AND PREVENTIVE ACTIONS ARE BEING INITIATED AS INFO DEVELOPS. THE COMPANY HAS CURRENTLY CEASED DISTRIBUTION AND MFG OF THE PRODUCT. THE COMPANY IS DEVELOPING A RECALL PLAN THAT WILL PROTECT PTS AND THAT ALSO CONSIDERS THE IMPORTANCE OF NOT DELAYING NECESSARY AND CRITICAL SURGERIES. THE COMPANY HAS SUFFICIENT STOCK OF A SUBSTITUTE PRODUCT TO SEND STERILE REPLACEMENTS TO THE HOSPITALS. THIS SUBSTITUTE PRODUCT OFFERS A ONE-WAY VENT VALVE AND IS ULTRASONICALLY WELDED AND DOES NOT USE A SIMILAR GLUE JOINT AS FOUND IN THE RECALLED PRODUCT. THIS PARTICULAR DESIGN DOES NOT OFFER AN ADJUSTABLE CONTROL KNOB, AND THAT FEATURE WILL NOT BE AVAILABLE WITH THE SUBSTITUTE PRODUCT.

    Description of Event or Problem · 1

    THIS NOTIFICATION HAS BEEN INITIATED DUE TO TWO REPORTED PRODUCT MALFUNCTIONS WITH THE 3-T L.V. CONTROL VALVE, 510(K) # (B)(4), A ONE-WAY VENT VALVE USED DURING CARDIOPULMONARY BYPASS SURGERY TO HELP PREVENT THE BUILD-UP OF EXCESS VACUUM PRESSURE WHEN SUCTIONING EITHER FROM THE HEART OR THE SURGICAL FIELD, AND TO HELP PREVENT INADVERTENT RETROGRADE FLOW AND AIR INTO THE HEART. IN BOTH OCCURRENCES, THE DEVICE CAME APART AT THE GLUE JOINT THAT HOLDS THE TWO HALVES TOGETHER. IN ONE OF THE TWO OCCURRENCES, THE ONE-WAY DUCKBILL VALVE FELL OUT. BOTH MALFUNCTIONS OCCURRED IN ROUTINE SETUP PRIOR TO THE PRODUCT BEING TAKEN INTO THE OPERATING ROOM. THE MALFUNCTIONS DID NOT INVOLVE ANY PTS AND NO DELAYS IN ANY SURGERIES WERE REPORTED. IN THE UNLIKELY EVENT THAT THE PRODUCT'S VENT VALVE USED FOR LEFT VENTRICULAR VENTING MALFUNCTIONS AT THE TIME THE AORTIC CLAMP IS REMOVED, PERFUSION FLOW COULD BE DISRUPTED POSSIBLY CAUSING INJURY TO THE PT. BOTH DEVICES WERE REPORTED TO BE FROM THE SAME LOT OF 200 PIECES. THE SECOND MALFUNCTION WAS CONFIRMED; THE DEVICE RELATED TO THE FIRST REPORTED MALFUNCTION WAS NOT RETURNED AND COULD NOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUCHOICE ADJUSTABLE VENT VALVE MJJ ALLIANT HEALTHCARE PRODUCTS 213-030NS 2010-09-16

    Patients

    Seq Age Sex Outcome Treatment
    1