BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING HEMOSTATIC VALVE

    MDR report key: 2183337 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05361
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 30, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DYB
    PMA / PMN Number
    K934624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT, AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED ROTATING HEMOSTATIC VALVE (RHV) NOTED BLOOD IN THE HOUSING AND ROTATOR. THERE WAS A CRACK IN THE DISTAL END OF THE ROTATOR. THE CRACK WAS 1 CM IN LENGTH BUT WAS IN A J SHAPE. THE O RINGS WERE INTACT. THE CAP WAS TIGHTLY CLOSED WHEN RETURNED. THERE WAS NO OTHER DAMAGE NOTED TO THE RHV. USING A NEW INDEFLATOR FILLED WITH WATER, THE RHV WAS PRESSURIZED AND FLUID LEAKED FROM THE CRACK. POTENTIAL CAUSES FOR A CRACKED ROTATOR INCLUDE, BUT ARE NOT LIMITED TO, DAMAGED DURING MANUFACTURING, MATERIALS, MOLD ANOMALIES, SHIPPING DAMAGE OR DAMAGED INDUCED DURING UNPACKING. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATA BASE FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO OTHER INCIDENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, IT WAS OBSERVED THAT THERE WAS A CRACK IN THE ROTATING HEMOSTATIC VALVE (RHV); THEREFORE, A NEW RHV WAS USED TO COMPLETE THE PROCEDURE. NO DIFFICULTY WAS NOTED WITH ANOTHER DEVICE, AND THERE WAS NO LEAK NOTED. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING HEMOSTATIC VALVE ACCESSORIES DYB AV-TEMECULA-CT 0121392

    Patients

    Seq Age Sex Outcome Treatment
    1