BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTEK DUO VENO-VENOUS CANNULA

    MDR report key: 9453962 · Received December 11, 2019

    Report

    Report Number
    2531527-2019-00055
    Event Type
    Death
    Date Received
    December 11, 2019
    Date of Event
    November 12, 2019
    Report Date
    December 11, 2019
    Manufacturer
    CARDIACASSIST INC.
    Product Code
    DWF
    PMA / PMN Number
    K160257
    Removal / Correction Number
    2531527-12/4/2019-001-CR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    VOLUNTARY MEDICAL DEVICE CORRECTION (REMEDIAL ACTION) WAS INITIATED BY THE MANUFACTURER VIA PHYSICIAN NOTIFICATION LETTER.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AN INCORRECT CANNULA WAS INCLUDED IN A TANDEMLIFE KIT DURING USE WITH A PATIENT. DURING PATIENT¿S CARE (PATIENT WAS REPORTEDLY IN POOR CONDITION UPON ARRIVAL AT FACILITY), THE PLANNED USE OF ONE DEVICE (PROTEK DUO KIT) WAS ABANDONED DUE TO THE PATIENT¿S WORSENING CONDITION (DROP IN BLOOD PRESSURE FROM 80 TO ~50). CUSTOMER OPENED A TANDEMLIFE KIT DUE TO THEIR NEED FOR USE OF OXYGENATOR, WHICH IS INCLUDED IN THE TANDEMLIFE KIT. THE PUMP AND OXYGENATOR WAS PRIMED AS NORMAL, AND THE 17FR ARTERIAL CANNULA WAS PLACED IN THE RIGHT FEMORAL ARTERY. INSTEAD OF PROTEK 24FR VENOUS CANNULA BEING PRESENT IN THE KIT, THE PROTEK DUO29FR WAS PRESENT AND USED IN THE RIGHT FEMORAL VEIN. FLOWS WERE REPORTEDLY LOW AT 2-2.3L/MIN AT 6,000RPM, AS THE CIRCUIT PULLED FROM THE DISTAL PORT OF THE 29FRPROTEK DUO. TROUBLESHOOTING FOR LOW FLOW WAS ATTEMPTED BY INCREASING THE RPMS; HOWEVER, CUSTOMER WAS UNABLE TO INCREASE THE FLOWS. PATIENT LATER EXPIRED, DUE TO CARDIOGENIC SHOCK AND METABOLIC ACIDOSIS. THE DEVICE HISTORY RECORDS FOR EACH INDIVIDUAL CANNULA AND THE OVERALL KIT WAS REVIEWED. OF THE TANDEMLIFE KITS (P/N 5740-2417) , 11 WERE BUILT WITH 29 FR PROTEKDUO CANNULAS INSTEAD OF 24 FR VENOUS CANNULAS UNDER TWO MANUFACTURING ORDERS, APR19096 AND APR19121. NO NON-CONFORMANCES WERE IDENTIFIED WITHIN THE DHRS OF THE INDIVIDUAL CANNULAS INVOLVED. BASED ON THE POOR CONDITION OF THE PATIENT PRIOR TO INTERVENTION WITH THE TANDEMLIFE KIT, THE INCORRECT CANNULA AND SUBSEQUENT LOW FLOW ARE NOT BELIEVED TO HAVE CAUSED THE PATIENT¿S DEATH, BUT IT'S CONTRIBUTION HAS NOT BEEN RULED OUT. THE DEVICES INVOLVED ARE NOT EXPECTED TO BE RETURNED BY THE SITE. ATTEMPTS TO THE PHYSICIAN FOR CLARIFYING INFORMATION ON THE RELATIONSHIP BETWEEN THE INCORRECT CANNULA/LOW FLOW AND THE PATIENT¿S DEATH HAVE BEEN MADE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243909 PROTEK DUO VENO-VENOUS CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF CARDIACASSIST INC. 5140-4629 215497

    Patients

    Seq Age Sex Outcome Treatment
    1 Death