BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE, O.P.S. BULK, N-S

    MDR report key: 3050634 · Received March 14, 2013

    Report

    Report Number
    1124841-2013-00074
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    December 13, 2012
    Report Date
    February 12, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTL
    PMA / PMN Number
    K820297
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO CARDIOVASCULAR SYSTEMS HAS RECEIVED THE ACTUAL DEVICE; HOWEVER, AN INVESTIGATION HAS YET TO BE COMPLETED. TERUMO WILL BE SUBMITTING A F/U REPORT WHEN MORE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS CORP (TCVS), ON (B)(6) 2013, THAT DURING CARDIOPULMONARY BYPASS THE OPS VALVE LEAKED. AT THAT TIME, BLOOD LOSS WAS NOT REPORTED TO TCVS MAKING THIS EVENT NOT REPORTABLE. ON (B)(6) 2013, IT WAS REPORTED TO TCVS THAT THE PERFUSIONIST REPORTED BLOOD SQUIRTING FROM THE VALVE, BUT GAVE NO INDICATION OF WHAT WAS LOST BEFORE THE LEAKED WAS STOPPED. THE AMOUNT OF BLOOD LOST DURING THE PROCEDURE IS UNK, AND MULTIPLE ATTEMPTS MADE TO ACQUIRE THE INFO HAVE BEEN UNSUCCESSFUL. TCVS IS PRO-ACTIVELY REPORTING THIS EVENT DUE TO THE BLOOD LOSS AND A DELAY IN CONTINUING SURGERY - THOUGH BOTH AMOUNTS AND TIME FRAMES ARE UNK AT THIS TIME. IT WAS REPORTED THAT THE OPS VALVE WAS CHANGED OUT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108480 VALVE, O.P.S. BULK, N-S OVERPRESSURE SAFETY VALVE DTL TERUMO CARDIOVASCULAR SYSTEMS CORP. NA PK27

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK