BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMLUNG OXYGENATOR

    MDR report key: 8160924 · Received December 13, 2018

    Report

    Report Number
    2531527-2018-00011
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    November 16, 2018
    Report Date
    January 11, 2019
    Manufacturer
    CARDIACASSIST INC
    Product Code
    DTZ
    PMA / PMN Number
    K153295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT STATE THAT THE DEVICE HAD BEEN RETURNED FOR ANALYSIS. DATE RECEIVED BY MANUFACTURER, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT STATE THAT THE DEVICE HAD BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE OXYGENATOR AND PRIMING TRAY CONTAINING THE PUMP WERE PERFORMED. NO ABNORMALITIES OR LEAKS WERE NOTED IN THE RECORD FOR THE OXYGENATOR PRIOR TO DISTRIBUTION. NO ABNORMALITIES WERE NOTED FOR THE PRIMING TRAY PRIOR TO DISTRIBUTION. THE PUMP AND OXYGENATOR WERE RETURNED FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS WAS NOT PERFORMED ON THE RETURNED PUMP. THE OXYGENATOR WAS FOUND TO FUNCTION AS INTENDED. NO LEAKS OR AIR ENTRAPMENT WERE OBSERVED WHEN RUNNING THE OXYGENATOR IN A CIRCUIT OR DURING LEAK TESTING. ADDITIONAL TESTING WAS PERFORMED IN ORDER TO DETERMINE HOW THE AIR COULD HAVE ENTERED THE SYSTEM. FROM THE RESULTS OF THIS TESTING, IT IS THOUGHT THAT A NEGATIVE PRESSURE WAS CREATED IN THE BLOOD PATHWAY WHEN ATTEMPTING TO REMOVE AN AIR BUBBLE FROM THE CIRCUIT. THE NEGATIVE PRESSURE ALLOWED AIR FROM THE GAS PATHWAY TO CROSS THE FIBER MEMBRANE INTO THE BLOOD PATHWAY. IT IS NOTED IN THE DIRECTIONS FOR USE THAT "POSITIVE PRESSURE MUST ALWAYS BE MAINTAINED ON THE BLOOD SIDE". NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BEING CONVERTED FROM A CARDIO PULMONARY BYPASS TO THE TANDEMLIFE HEART PUMP FOR VENOUS EXTRACORPOREAL LIFE SUPPORT. THE PUMP WAS PRIMED IN STANDARD FASHION AND WAS OBSERVED TO BE FREE OF AIR. AFTER SUCCESSFULLY CANNULATING VIA THE RIGHT INTERNAL JUGULAR VEIN AND CONFIRMING CANNULA POSITION VIA FLUOROSCOPY, WET-TO-WET CONNECTIONS WERE MADE. A SMALL AIR BUBBLE WAS NOTED, BUT WAS EVACUATED VIA A 20CC SYRINGE. SUPPORT WAS INITIATED. APPROXIMATELY 10 SECONDS LATER, A LARGE BUBBLE WAS NOTED WITHIN THE TANDEMLUNG OXYGENATOR. SUPPORT WAS STOPPED AND AN ATTEMPT WAS MADE TO EVACUATE THE AIR FROM THE CIRCUIT USING THE LUER PORT WHICH APPEARED TO BE SUCCESSFUL. AS SUPPORT WAS ABOUT TO RESUME, MORE AIR WAS NOTED. THIS CIRCUIT WAS ATTEMPTED TO BE EVACUATED WITH AIR AGAIN, BUT A STREAM OF FOAM WAS ENCOUNTERED. A FINAL ATTEMPT WAS MADE TO EVACUATE THE AIR BY CUTTING OUT THE CIRCUIT, FLUSHING WITH SALINE, AND RE-PRIMING, BUT WAS UNSUCCESSFUL. THE CANNULA WAS THEN CONNECTED TO THE CARDIOHELP SYSTEM AND THE SUPPORT WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000180 TANDEMLUNG OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ CARDIACASSIST INC 5160-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR