BEUDAMED
    FDA Adverse Event Death Summary report: N

    XLUNG KIT 230

    MDR report key: 11671055 · Received April 15, 2021

    Report

    Report Number
    3012172416-2021-00009
    Event Type
    Death
    Date Received
    April 15, 2021
    Date of Event
    February 6, 2021
    Report Date
    May 27, 2021
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. AS A LOT NUMBER COULD NOT BE DETERMINED, DEVICE HISTORY AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CRITICALLY ILL PATIENT WAS ADMITTED TO THE HOSPITAL WITH A COVID-19 INFECTION AND WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) ON THE NOVALUNG CONSOLE UTILIZING THE XLUNG 230 OXYGENATOR. ON DAY 4 OF ECMO SUPPORT ((B)(6) 2021), IT WAS REPORTED THE PATIENT DEVELOPED RED TINGED URINE OF UNKNOWN ETIOLOGY. A RESIDENT PHYSICIAN DETERMINED THE RED TINGED URINE AS A SIGN OF HEMOLYSIS, AND THEY DECIDED TO EXCHANGE THE XLUNG 230 OXYGENATOR WITH A MAQUET ROTAFLOW (NOT A FRESENIUS PRODUCT). THE PATIENT RECEIVED A BLOOD TRANSFUSION TO CORRECT HEMOLYTIC ANEMIA AND AFTER THE OXYGENATOR WAS EXCHANGED, HEMOLYSIS IMPROVED FOR A BRIEF PERIOD BEFORE RETURNING. HEMATOCRIT AND HEMOGLOBIN LABORATORY FINDINGS WERE NOT REPORTED AND REMAIN UNKNOWN. IT WAS REPORTED THE PATIENT SUBSEQUENTLY EXPIRED AFTER SUCCESSFULLY WEANING FROM ECMO SUPPORT; HOWEVER, THE EXACT TIME AND DATE OF THE PATIENT'S DEATH WERE UNKNOWN. IT WAS INITIALLY REPORTED BY THE CHIEF PERFUSIONIST THAT THE DEATH OF THE PATIENT WAS UNRELATED TO THE NOVALUNG SYSTEM, HOWEVER, CONCERN WAS EXPRESSED REGARDING THE HIGH PUMP REVOLUTIONS PER MINUTE (RPM) AND HIGH OXYGENATOR TRANSMEMBRANE PRESSURES. A DISCUSSION WITH THE DIRECTOR OF CRITICAL CARE REVEALED THE DETERMINATION OF HEMOLYSIS WAS BASED ON HEMOLYZED LABS AND THE PATIENT¿S PINK TINGED URINE. MEDICAL IMAGING TAKEN PRIOR TO THE INITIATION OF ECMO SUPPORT SHOWED NO EVIDENCE OF CLOTS, YET ANTICOAGULATION STRATEGIES THROUGHOUT ECMO SUPPORT WERE NOT REPORTED. IT WAS THE DIRECTOR¿S CONTENTION THAT THE DEVELOPMENT OF AN ACUTE KIDNEY INJURY, SECONDARY TO HEMOLYTIC ANEMIA, CONTRIBUTED, IN PART, TO THE PATIENT¿S EXPIRATION; HOWEVER, THE EXACT CAUSE OF DEATH WAS NOT PROVIDED. FURTHERMORE, SPECIFIC PATIENT INFORMATION, FURTHER DETAILS CONCERNING THE HOSPITALIZATION, ECMO SETTINGS, ECMO SUPPORT DURATION AND LABORATORY RESULTS WERE NOT PROVIDED. THERE WAS NO REPORT OF THE XLUNG 230 OXYGENATOR AND/OR THE DELTASTREAM DP3 PUMP BEING AVAILABLE FOR PRODUCT INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL INVESTIGATION: A TEMPORAL RELATIONSHIP EXISTS BETWEEN ECMO SUPPORT UTILIZING THE NOVALUNG CONSOLE WITH THE DELTASTREAM DP3 PUMP, THE XLUNG 230 OXYGENATOR AND THE EVENT OF A HEMOLYSIS LEADING TO AN ACUTE KIDNEY INJURY. A TEMPORAL RELATIONSHIP DOES NOT EXIST BETWEEN ECMO SUPPORT AND THE PATIENT¿S EXPIRATION AS IT WAS REPORTED THE PATIENT SUCCESSFULLY WEANED FROM ECMO PRIOR TO THEIR DEATH. IT IS WELL ESTABLISHED UNDERGOING ECMO PRESENTS A HIGH RISK OF HEMOLYSIS DUE TO THE PATHOPHYSIOLOGICAL RESPONSE OF CRITICALLY ILL PATIENTS TO THE MECHANISMS OF EXTRACORPOREAL SUPPORT. ADDITIONALLY, HEMOLYSIS IS AN ANTICIPATED MECHANICAL COMPLICATION OF ECMO DUE TO THE SHEARING FORCES OF BLOOD THROUGH THE PUMP AND ACROSS THE TRANSMEMBRANE OF THE OXYGENATOR. IN THIS CASE, A DIAGNOSIS OF COVID-19 AND ITS EFFECT ON ECMO SUPPORTED PATIENTS CAN BE MULTIFACTORIAL AND POTENTIALLY INVOLVE OTHER COMORBIDITIES. IN THE ABSENCE OF REPORTED LABORATORY RESULTS, ECMO SETTINGS, PATIENT COMORBIDITIES, PUMP AND/OR OXYGENATOR PRODUCT INVESTIGATION, THE RELATIONSHIP BETWEEN THESE EVENTS AND THE USE OF ANY FRESENIUS AND/OR XENIOS PRODUCTS CANNOT BE DETERMINED. BASED ON THE AVAILABLE INFORMATION, AN ALLEGATION EXISTS STATING HIGH DELTASTREAM DP3 PUMP RPMS AND HIGH XLUNG 230 OXYGENATOR TRANSMEMBRANE PRESSURES MAY HAVE BEEN THE SOURCE OF HEMOLYSIS, ACUTE KIDNEY INJURY AND CONTRIBUTED, IN PART, TO THE PATIENT¿S DEATH; HOWEVER, THERE IS NO SUPPORTING OBJECTIVE EVIDENCE INDICATING A FRESENIUS/ XENIOS DEVICE(S) OR PRODUCT(S) DEFICIENCY OR MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT¿S SERIOUS ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRITICALLY ILL PATIENT WAS ADMITTED TO THE HOSPITAL WITH A COVID-19 INFECTION AND WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) ON THE NOVALUNG CONSOLE UTILIZING THE XLUNG 230 OXYGENATOR. ON DAY 4 OF ECMO SUPPORT (B)(6) 2021, IT WAS REPORTED THE PATIENT DEVELOPED RED TINGED URINE OF UNKNOWN ETIOLOGY. A RESIDENT PHYSICIAN DETERMINED THE RED TINGED URINE AS A SIGN OF HEMOLYSIS, AND THEY DECIDED TO EXCHANGE THE XLUNG 230 OXYGENATOR WITH A MAQUET ROTAFLOW (NOT A FRESENIUS PRODUCT). THE PATIENT RECEIVED A BLOOD TRANSFUSION TO CORRECT HEMOLYTIC ANEMIA AND AFTER THE OXYGENATOR WAS EXCHANGED, HEMOLYSIS IMPROVED FOR A BRIEF PERIOD BEFORE RETURNING. HEMATOCRIT AND HEMOGLOBIN LABORATORY FINDINGS WERE NOT REPORTED AND REMAIN UNKNOWN. IT WAS REPORTED THE PATIENT SUBSEQUENTLY EXPIRED AFTER SUCCESSFULLY WEANING FROM ECMO SUPPORT; HOWEVER, THE EXACT TIME AND DATE OF THE PATIENT'S DEATH WERE UNKNOWN. IT WAS INITIALLY REPORTED BY THE CHIEF PERFUSIONIST THAT THE DEATH OF THE PATIENT WAS UNRELATED TO THE NOVALUNG SYSTEM, HOWEVER, CONCERN WAS EXPRESSED REGARDING THE HIGH PUMP REVOLUTIONS PER MINUTE (RPM) AND HIGH OXYGENATOR TRANSMEMBRANE PRESSURES. A DISCUSSION WITH THE DIRECTOR OF CRITICAL CARE REVEALED THE DETERMINATION OF HEMOLYSIS WAS BASED ON HEMOLYZED LABS AND THE PATIENT¿S PINK TINGED URINE. MEDICAL IMAGING TAKEN PRIOR TO THE INITIATION OF ECMO SUPPORT SHOWED NO EVIDENCE OF CLOTS, YET ANTICOAGULATION STRATEGIES THROUGHOUT ECMO SUPPORT WERE NOT REPORTED. IT WAS THE DIRECTOR¿S CONTENTION THAT THE DEVELOPMENT OF AN ACUTE KIDNEY INJURY, SECONDARY TO HEMOLYTIC ANEMIA, CONTRIBUTED, IN PART, TO THE PATIENT¿S EXPIRATION; HOWEVER, THE EXACT CAUSE OF DEATH WAS NOT PROVIDED. FURTHERMORE, SPECIFIC PATIENT INFORMATION, FURTHER DETAILS CONCERNING THE HOSPITALIZATION, ECMO SETTINGS, ECMO SUPPORT DURATION AND LABORATORY RESULTS WERE NOT PROVIDED. THERE WAS NO REPORT OF THE XLUNG 230 OXYGENATOR AND/OR THE DELTASTREAM DP3 PUMP BEING AVAILABLE FOR PRODUCT INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571467 XLUNG KIT 230 QJZ QJZ XENIOS AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R NOVALUNG CONSOLE| NOVALUNG CONSOLE| NOVALUNG CONSOLE