BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERPRESSURE SAFETY VALVE

    MDR report key: 4938350 · Received July 22, 2015

    Report

    Report Number
    1124841-2015-00216
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    March 9, 2015
    Report Date
    July 30, 2015
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K820297
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEM IN THE INITIAL REPORT SUBMITTED TO THE FDA ON JULY 22, 2015. (B)(4). METHOD - ACTUAL DEVICE EVALUATED. METHOD - VISUAL INSPECTION. METHOD - PRESSURE TESTING. RESULTS - NO FAILURE DETECTED. CONCLUSIONS - UNABLE TO CONFIRM COMPLAINT. THE ACTUAL SAMPLE WAS VISUALLY INSPECTED UPON RECEIPT, DURING WHICH NO ANOMALIES WERE NOTED. THE SAMPLE WAS PRESSURE TESTED TO RECREATE THE 100% IN-PROCESS LEAK TEST THAT ALL OPS VALVES ARE SUBJECTED TO PRIOR TO RELEASE. THE SAMPLE WAS PRESSURIZED TO 3.5 PSI USING A SYRINGE AND SUBMERGING THE UNIT UNDER WATER. NO LEAKS WERE FOUND. ALL OTHER FUNCTIONAL PARAMETERS WERE ALSO TESTED TO VERIFY THAT THE VALVE WAS PERFORMING PER TCVS SPECIFICATIONS. BOTH PRESSURE RELIEF UMBRELLAS AND DUCKBILL FLOW WERE FOUND TO BE OPERATING AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AND THE COMPLAINT WAS NOT CONFIRMED. CURRENTLY, 100% OF OPS PRODUCT IS VERIFIED ON AN IN-PROCESS LEAK TEST TO ENSURE ADHERENCE TO TCVS SPECIFICATIONS. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORPORATION THAT AFTER CARDIOPULMONARY BYPASS IT WAS FOUND THAT THE SAFETY VALVE HAD LEAKED BLOOD DURING THE CASE. THERE WAS A BLOOD LOSS OF ABOUT 10CC. THE SURGERY HAD BEEN COMPLETED SUCCESSFULLY. THIS EVENT WAS INITIALLY DEEMED NOT REPORTABLE. (INFORMED DATE (B)(6) 2015) AS NO INJURIES HAD OCCURRED. A SIMILAR REPORT WAS DETERMINED TO HAVE CAUSED OR CONTRIBUTED TO SERIOUS INJURY ON (B)(6) 2015, CAUSING THIS EVENT TO BECOME REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475566 OVERPRESSURE SAFETY VALVE VALVE, O.P.S BULK, N-S FOR TC KFM TERUMO CARDIOVASCULAR SYSTEMS CORP. LN130BJ RK04

    Patients

    Seq Age Sex Outcome Treatment
    1 NA