BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILLIAM HARVEY OVER PRESSURE SAFETY VALVE

    MDR report key: 1493064 · Received August 19, 2009

    Report

    Report Number
    1124841-2009-00029
    Event Type
    Malfunction
    Date Received
    August 19, 2009
    Date of Event
    July 20, 2009
    Report Date
    July 23, 2009
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    MNJ
    PMA / PMN Number
    K820297A
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT THE PRESSURE RELIEF VALVE MAY HAVE EXHIBITED A CRACK DUE TO THE "SPRAY OF BLOOD" THAT WAS OBSERVED IN A VENT LINE DURING A CARDIOPULMONARY BYPASS PROCEDURE. THE USER FACILITY DID NOT MAINTAIN THE DEVICE - AND IMMEDIATELY DISCARDED IT AFTER REMOVING FROM THE CIRCUIT. TERUMO'S INVESTIGATION (INCLUDING INTERVIEWS WITH THE USER FACILITY) REVEALED THAT THE DEVICE MOST LIKELY PERFORMED EXACTLY IT IS INTENDED IN THAT THE POSITIVE PRESSURE UMBRELLA "ACTIVATED" WHEN THERE WAS A PRESSURE INCREASE IN THE CIRCUIT. TERUMO DRAWS THIS CONCLUSION BASED UPON THE "SPRAY" THAT WAS DESCRIBED IN THE COMPLAINT. IF THE DEVICE HAD BEEN DEFECTIVE/CRACKED, THE LIKELY SCENARIO IS THAT FLUID WOULD LEAK FROM THE VALVE AND WOULD NOT HAVE SPRAYED FROM THE VALVE. TERUMO DOES NOT CONSIDER THIS EVENT TO BE THE RESULT OF A DEFECTIVE PRODUCT, BUT RATHER THE RESULT OF ANOTHER EVENT THAT OCCURRED DURING THE OPERATIONAL CONTEXT OF THE SURGERY. THE VALVE APPEARS TO HAVE PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    ON JULY 23, 2009, IT WAS REPORTED BY A USER FACILITY ((B) (4)) TO TERUMO CARDIOVASCULAR THAT DURING A CARDIOPULMONARY BYPASS PROCEDURE, AN OVERPRESSURE RELIEF VALVE MAY HAVE EXHIBITED A CRACK DURING USE. AS A RESULT OF THIS EVENT, THE DEVICE WAS REPLACED AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER INCIDENT. THE USER FACILITY REPORTED THAT THE PT DID NOT SUFFER INJURY OF ANY TYPE AS A RESULT OF THIS EVENT (ALTHOUGH IT IS APPARENT THAT THERE WAS MINIMAL/INSIGNIFICANT BLOOD LOSS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILLIAM HARVEY OVER PRESSURE SAFETY VALVE PRESSURE RELIEF VALVE MNJ TERUMO CARDIOVASCULAR SYSTEMS CORP. NA LC04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK