BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFFINITY NT I-CVR/HFO 541

    MDR report key: 2867739 · Received December 11, 2012

    Report

    Report Number
    2184009-2012-00080
    Event Type
    Death
    Date Received
    December 11, 2012
    Date of Event
    September 29, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DTZ
    PMA / PMN Number
    K932252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: UPON RECEIPT AT MEDTRONIC'S QUALITY LABORATORY, VISUAL INSPECTION SHOWED NO OUTWARD SIGNS OF PHYSICAL DAMAGE OR ABNORMALITIES. BLOOD SIDE PRESSURE INTEGRITY TESTING WAS PERFORMED AT THREE LITERS PER MINUTE WITH TWENTY-THREE PSI OF BACK PRESSURE FOR TEN MINUTES. PRESSURE INTEGRITY TESTING SHOWED NO INTERNAL OR EXTERNAL LEAKS. GAS TRANSFER TESTING AT 7 LITERS PER MINUTE REVEALED OXYGEN AND CARBON DIOXIDE TRANSFER WERE SLIGHTLY LOWER THAN HISTORICAL AVERAGES. THE BLOOD SIDE PRESSURE DROP TESTED SLIGHTLY HIGHER THAN HISTORICAL AVERAGES. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS PRODUCT MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. NO DESIGN OR MANUFACTURING ANOMALIES WERE FOUND DURING ANALYSIS THAT WOULD HAVE CAUSED/CONTRIBUTED TO THIS EVENT. ANALYSIS DID NOT IDENTIFY ANY FUNCTIONAL ANOMALIES OR DAMAGE TO THE PRODUCT. PERFORMANCE TESTING DETECTED SLIGHTLY LOWER GAS TRANSFER AS COMPARED TO HISTORICAL AVERAGES. IT IS EXPECTED THAT USED DEVICES WOULD HAVE SLIGHTLY LOWER GAS TRANSFER LEVELS THAN A NEW DEVICE AND THE TRANSFER LEVELS OF USED DEVICES CAN VARY DEPENDING ON THE USE CONDITIONS OF THE DEVICE. ANALYSIS OF PERFORMANCE DATA CONCLUDED THE LOW GAS TRANSFER AS COMPARED TO HISTORICAL AVERAGES OF USED DEVICES IS CONSISTENT WITH OTHER DEVICES WHERE A PROTEIN BUILD UP OR CRYOPRECIPITATE CAUSED FLOW RESTRICTION IN DEVICE. THIS IS SUPPORTED BY THE FACT THE PHENOMENA WENT AWAY WHEN THE OXYGENATOR WAS CHANGED OUT. THE EVENT DESCRIPTION ALSO IDENTIFIED SEVERAL PATIENT CONDITIONS WHICH MAY HAVE CONTRIBUTED TO THE LOW GAS TRANSFER. ADDITIONALLY, REVIEW OF THE PUMP RECORDS DETERMINED THAT THE PATIENT WAS NOT FULLY SUPPORTED TO THE EXTENT THEY MAY HAVE BEEN AS EVIDENCED BY THE USER'S DECISION TO CHANGE OUT THE OXYGENATOR WITHOUT IMPLEMENTING ALL POSSIBILITIES TO IMPROVE THE CLINICAL PICTURE (E.G. INCREASE FIO2 AND INCREASE GAS FLOW). (B)(6). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING AN EMERGENCY CASE TO "EXCHANGE THE AORTA", IT WAS REPORTED THAT THE VENOUS SATURATION OF THIS AFFINITY OXYGENATOR WAS LOW. THE PATIENT HAD PREVIOUSLY UNDERGONE A DOUBLE VALVE REPLACEMENT AND WAS ADMITTED INTO THE HOSPITAL EMERGENCY DEPARTMENT FOR SEVERE CARDIAC DYSFUNCTION AND EXCESSIVE BLEEDING (UNKNOWN ORIGIN). BEFORE USE OF THE OXYGENATOR, THE HEMOGLOBIN WAS 9G/DL. VALUES REPORTED DURING THE SURGERY WERE: HB 4.3G/DL, PARTIAL PRESSURE OF OXYGEN 236.6MMHG, PARTIAL PRESSURE OF CARBON DIOXIDE 38.8MMHG, MIXED VENOUS SATURATION 79%, OXYGEN CONCENTRATION 45%, FLOW RATE 3390ML/MIN, AND VENTILATOR VOLUME OF 1.7L/MIN. AFTER REWARMING, THE VALUES WERE: HB7.2 G/DL, PARTIAL PRESSURE OF OXYGEN 64-68MMHG, MIX VENOUS SATURATION BELOW 61%, FLOW RATE 4600ML/MIN, AND VENTILATOR VOLUME 2.1L/MIN. THE VENOUS SATURATION WAS STILL LOW AND THE DECISION WAS MADE TO CHANGE OUT THE DEVICE FOR A NON-MEDTRONIC OXYGENATOR. HOWEVER, THE PATIENT EXPIRED PRIOR TO COMPLETION OF THE SURGERY. FURTHER INFORMATION INDICATED THAT THE PATIENT HAD A HISTORY OF MULTIPLE HEALTH ISSUES INCLUDING DIABETES, HYPO-THYROIDISM, RENAL FAILURE, AND POOR HEMODYNAMICS. THE PHYSICIAN REPORTED THAT THE PATIENT'S COMORBIDITIES, NOT THE PERFORMANCE OF THE AFFINITY OXYGENATOR WERE THE CAUSE OF THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFFINITY NT I-CVR/HFO 541 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MEDTRONIC PERFUSION SYSTEMS 95214 11940045

    Patients

    Seq Age Sex Outcome Treatment
    1 Death