BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS INVENT CANNULAE

    MDR report key: 3202079 · Received June 27, 2013

    Report

    Report Number
    1828100-2013-00616
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWF
    PMA / PMN Number
    K905638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE DOCTOR TRIED TO RE-INSERT THE STYLET AND PUSHED IT THROUGH ONE OF THE ARTERIAL VENT HOLES. THERE WAS A DELAY OF APPROX TWO MINUTES. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO BLOOD LOSS OR NO ADVERSE CONSEQUENCES TO THE PT. PER CLINICAL REVIEW ON (B)(6) 2013: THE CARDIOVASCULAR (CV) SURGEON NEEDED TO REPOSITION THE VENT CATHETER/CANNULA. THE STYLET WAS RE-INSERTED AND WAS PUSHED THROUGH ONE OF THE SIDE HOLES OF THE VENT CATHETER/CANNULA (AND NOT THE TIP). THE STYLET WAS REMOVED, AND THE VENT CATHETER/CANNULA WAS REMOVED AND REPLACED WITH ANOTHER VENT. THERE WAS NO INJURY TO THE HEART. THERE WAS A DELAY OF TWO MINUTES IN THE PROCEDURE, AS THE VENT WAS REPLACED. THERE WAS NO LOSS OF BLOOD AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM OBSERVED OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293336 SARNS INVENT CANNULAE DWF TERUMO CARDIOVASCULAR SYSTEMS CORP. 18124 0691561

    Patients

    Seq Age Sex Outcome Treatment
    1