BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR

    MDR report key: 1053411 · Received May 23, 2008

    Report

    Report Number
    2184009-2008-00040
    Event Type
    Injury
    Date Received
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K973760
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL, SERIAL, AND LOT NUMBER WERE UNABLE TO BE OBTAINED; THEREFORE, WE WERE UNABLE TO PERFORM A DEVICE HISTORY REVIEW. RESULTS: THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS AND THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. CONCLUSION: BASED ON THE LIMITED PRODUCT INFORMATION RECEIVED AND WITHOUT PRODUCT RETURN, THE CAUSE OF THESE EVENTS CANNOT BE DETERMINED. CONCLUSION: ON APRIL 8, 2008, MEDTRONIC WAS NOTIFIED BY FDA THAT A CONTAMINANT HAD BEEN DISCOVERED IN RECENTLY-MANUFACTURED HEPARIN. MEDTRONIC MANUFACTURES SEVERAL PERFUSION PRODUCTS THAT ARE COATED WITH CHEMICALS CONTAINING HEPARIN, MANY OF WHICH ARE USED TO MAKE A BYPASS AND/OR ECMO CIRCUIT. IT IS DIFFICULT TO ESTIMATE THE TOTAL QUANTITY OF HEPARIN CONTAINED IN THIS PARTICULAR CIRCUIT, FOR THIS PARTICULAR CASE, HOWEVER, WE WOULD EXPECT TO SEE APPROXIMATELY 0.73 MG OF HEPARIN IN A TRILLIUM COATED OXYGENATOR, THE SURFACE AREA OF WHICH ACCOUNTS FOR 2.72 SQUARE METERS OF AN ESTIMATED 3.32 SQUARE METERS IN A TYPICAL BYPASS CIRCUIT. WE ARE SUBMITTING THE 5-DAY REPORT AS REQUESTED BY FDA, BUT HAVE NOT HAD SUFFICIENT OPPORTUNITY SINCE RECEIVING NOTICE ON 05/16/2008 TO DETERMINE WHETHER THE DEVICE OR THE HEPARIN CONTAINED IN THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. AS THE LOT NUMBER OF THIS PRODUCT WAS NOT PROVIDED AND THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS, MEDTRONIC CANNOT, AT THIS TIME, DETERMINE IF THE PRODUCT WAS MANUFACTURED WITH THE CONTAMINANT DESCRIBED IN FDA'S APRIL 8, 2008 NOTIFICATION. NOR COULD WE DETERMINE AT THIS TIME, WHETHER THE DEVICE OR THE HEPARIN CONTAINED ON THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT SHORTLY AFTER DELIVERING 4:1 BLOOD CARDIOPLEGIA (300 TO 400CC PER DOSE), SEVERAL PATIENT'S HAVE EXPERIENCED BRIEF HYPOTENSION WHERE THE PRESSURE DECREASES TO APPROXIMATELY 30MMHG. IT WAS NOTED THE RESPONSE WAS MORE PROFOUND WITH REPEAT DOSES OF CARDIOPLEGIA, RATHER THAN THE INITIAL DOSE. THE PERFUSIONIST INDICATED THAT THEY HAD OBSERVED THE HYPOTENSION INTERMITTENTLY SINCE EARLY 2008; HOWEVER, ATTRIBUTED IT TO ANESTHESIA. IT WAS NOTED THAT THE HYPOTENSION WAS NOT OBSERVED WHILE USING NEOSYNEPHRINE, WHICH RESOLVED THE ISSUE. THE PATIENT'S CONCOMITANT MEDICATIONS AND ALLERGIES WERE NOT PROVIDED. IT WAS UNKNOWN WHETHER SYSTEMIC INTRAVENOUS HEPARIN OR SUBCUTANEOUS HEPARIN WAS ADMINISTERED DURING, OR IN PROXIMITY TO, THE USE OF THESE TRILLIUM COATED PRODUCTS. IN SUMMARY, THERE HAVE BEEN AN ESTIMATED 16 OCCURRENCES FROM THIS FACILITY, 13 OF WHICH ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED. THIS REPORT IS THE FIFTH OF THESE 13 REPORTS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED AND ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE INCIDENT HAVE BEEN UNSUCCESSFUL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR DTZ MEDTRONIC PERFUSION SYSTEMS 511T NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R IN THE HEPARIN USED TO COAT THESE PRODUCTS.| CANNOT DETERMINE IF THE CONTAMINANT WAS CONTAINED| PROCEDURES WERE AN UNKNOWN MODEL| LOT OF TRILLIUM COATED CUSTOM CIRCUITS. MEDTRONIC| THE CONCOMITANT PRODUCTS USED DURING THESE