BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER AND CANNULA

    MDR report key: 3901557 · Received February 3, 2014

    Report

    Report Number
    1828100-2014-00052
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    January 8, 2014
    Report Date
    January 10, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWF
    PMA / PMN Number
    K934127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION 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 (CPB) PROCEDURE, THE CUSTOMER FOUND AIR BUBBLES ENTRAINED IN THE TUBING OF THE ARTERIAL CANNULA. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THERE WAS A DELAY OF THREE TO FIVE MINUTES FOR THE STOP OF CPB AND THE CANNULA WAS REPLACED. THERE WAS ALSO BLOOD LOSS OF LESS THAN 1CC. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. PER CLINICAL REVIEW ON (B)(6) 2014: ON THE INITIATION OF CARDIOPULMONARY BYPASS, BUBBLES WERE OBSERVED IN THE TUBING OF THE SOFT FLOW AORTIC CANNULA. CPB WAS TERMINATED AND THE SURGICAL TEAM ELECTED TO REMOVE THE CANNULA AND RE-PLACE WITH ANOTHER AORTIC CANNULA. CPB WAS TERMINATED PRIOR TO AORTIC CROSS-CLAMPING AND PRIOR TO CARDIOPLEGIC ARREST. THIS WOULD RESULT IN BEING ABLE TO TERMINATE CARDIOPULMONARY BYPASS IN A CONTROLLED STATE WHERE THE HEART IS BEATING ADEQUATELY AND BLOOD PRESSURE IS MONITORED AND CAN BE CONTROLLED BY THE ANESTHESIOLOGIST. THE CANNULA WAS REPLACED AS THE BUBBLE IN THE TUBE WALL COULD APPEAR TO BE A BUBBLE IN THE BLOOD STREAM. THE CANNULA WAS REMOVED AND A REPLACEMENT WAS PLACED IN THE SAME AORTOTOMY SITE. AFTER THE NEW CANNULA IS PLACED, IT WOULD BE DEBUBBLED AND THEN CONNECTED TO THE ARTERIAL LINE TUBING OF THE PERFUSION CIRCUIT. THERE WOULD USUALLY BE SOME BLOOD LOSS DURING THIS PROCESS, BUT THE LOST BLOOD CAN BE RETURNED TO THE PATIENT THROUGH THE PUMP SUCKERS BACK TO THE PERFUSION CIRCUIT. AS A RESULT, THE NEW BLOOD LOSS IS VERY SMALL AND IN THIS CASE WAS REPORTED TO BE ABOUT 1 ML. THE PROCESS OF CANNULA REMOVAL AND PLACEMENT OF A NEW CANNULA THAT INCLUDES DE-AIRING AND CONNECTION TO THE PERFUSION CIRCUIT WOULD TAKE ABOUT THREE TO FIVE MINUTES TO COMPLETE. THE COMPLAINT REPORT DESCRIBES THAT NO DELAY IN THE PROCEDURE WAS EXPERIENCED, BUT CARDIOPULMONARY BYPASS WAS SUSPENDED AND A NEW CANNULA PLACED AND A DELAY OF THREE TO FIVE MINUTES IS A REASONABLE ESTIMATE. AFTER THE NEW CANNULA WAS PLACED AND DE-BUBBLED, CARDIOPULMONARY BYPASS WAS RE-STARTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT HARM OBSERVED OR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71748 CATHETER AND CANNULA SARNS SOFT FLOW AORTIC CANNULA DWF TERUMO CARDIOVASCULAR SYSTEMS CORP. 5768

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention