BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM TUBING PACK

    MDR report key: 20366449 · Received October 4, 2024

    Report

    Report Number
    6000033-2024-00035
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 5, 2024
    Report Date
    October 4, 2024
    Manufacturer
    CARDIAC SURGERY MFG KERKRADE
    Product Code
    DWE
    PMA / PMN Number
    K171979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A FUSION OXYGENATOR AND CUSTOM TUBING PACK, IT WAS REPORTED THAT THE CUSTOMER STARTED CIRCULATION EXTRA-CORPORELLE (CEC), THE DEVICE INCREASED IN PRESSURE AND IT WAS IMPOSSIBLE TO INJECT ON THE AORTIC CANNULA. THE CUSTOMER STOPPED THE CEC AS THEY SUSPECTED A THROMBOSED CANNULA. THE CANNULA WAS REPLACED. BLOOD WAS RETURNED TO THE CEC VIA THE CARDIOPLEGIA CIRCUIT THROUGH THE RIGHT ATRIUM. THE CUSTOMER STARTED A NEW CEC, HOWEVER, IT WAS IMPOSSIBLE TO INJECT AND THERE WAS A THROMBOSED OXYGENATOR. THE CIRCUIT AND CANNULAE WERE THEN REPLACED. BEFORE THE CEC, THE BYPASS ACT WAS GREATER THAN 400 SECONDS. AT THE END OF THE BYPASSES, THE ACT WAS 392 SECONDS. THERE WAS AN ADDITION OF 5000 UNITS IN THE CIRCUIT AND 5000 UNITS IN THE PATIENT. 5000IU OF HEPARIN WAS ADDED IN THE KTC CONTROL AND THE ACT WAS GREATER THAN 600 SECONDS AFTER THE ADDITION. THE ACT WAS GREATER THAN 500 SECONDS AT THE START OF THE CEC. THE OXYGENATOR AND THE COMPLETE CEC CIRCUIT WERE REPLACED WITH A NEW MEDTRONIC PACK TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULAE WERE NOT PART OF THE CUSTOM TUBING PACK. THEY WERE THE CANNULAE IN THE PATIENT. THE CANNULAE USED WERE THE SORIN GROUP ARTERIAL CANNULA AND THE EDWARDS ATRIOCAVE CANNULA. THE BLOCKAGE APPEARED TO COME ONLY FROM THE OXYGENATOR AND SOME THROMBI WAS IN THE ARTERIAL LINE WHICH WAS PUSHED BY THE PUMP. THE SORIN CANNULA WAS BEING EQUIPPED WITH A SIEVE, HOWEVER, THEY STOPPED THERE. THE VENOUS LINE WAS NORMAL. THE ISSUE OCCURRED AT THE START OF THE CEC, THEREFORE, THE CUSTOMER NEVER HAD ANY ARTERIAL FLOW. THE CEC WAS PURGED WITH APPROXIMATELY 1200ML OF ISOFUSINE SOLUTION. THERE WAS ALSO 5000IU OF HEPARIN AND 1G OF CEFAZOLIN. THE PATIENT WAS ON HEPARIN SODIUM PANFARMA. THE EFFECTIVENESS OF THE HEPARIN WAS EVALUATED WITH THE HEMOCRON. THE CEC WAS IN NORMOTHERMIA AT 37 DEGREES CELSIUS. THE CUSTOMER DID NOT INTRODUCE AIR INTO THE CEC. THE FIBRIN DEVELOPED QUICKLY. THE CUSTOMER USED MEDTRONIC'S CENTRIFUGAL PUMPS. THE CUSTOMER HAD 2 LITERS IN THE CARDIOTOMY VENOUS RESERVOIR (CVR) WHEN THEY CLAMPED THE VEIN DUE TO A LACK OF ARTERIAL FLOW, KNOWING THAT THEY STILL HAD THE PRIMING OF 1200ML OF ISOFUDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402684 CUSTOM TUBING PACK TUBING, PUMP, CARDIOPULMONARY BYPASS DWE CARDIAC SURGERY MFG KERKRADE M333519K 229015452

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown