BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XLUNG KIT 230

    MDR report key: 11826675 · Received May 14, 2021

    Report

    Report Number
    3012172416-2021-00017
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    April 6, 2021
    Report Date
    June 23, 2021
    Manufacturer
    XENIOS AG
    Product Code
    QJZ
    PMA / PMN Number
    K191407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR A MANUFACTURER EVALUATION. NO IRREGULARITIES WERE IDENTIFIED DURING REVIEW OF THE MANUFACTURING RECORDS. A REVIEW OF THE RESPECTIVE BATCH RECORDS DID NOT SHOW ANY EVIDENCE OF A NON-CONFORMANCE DURING THE MANUFACTURING PROCESS. THE LOG DATA FROM (B)(6) 2021 TO (B)(6) 2021 WAS REVIEWED AND SHOWED THAT THE TREATMENT WAS CARRIED OUT WITH A HIGH BLOOD FLOW OF AROUND 6,000 ML/MIN, WITH A BLOOD FLOW MOSTLY ABOVE 6,000 ML/MIN. HOWEVER, THE AVAILABLE INFORMATION DID NOT MAKE IT POSSIBLE TO EVALUATE THE PERFORMANCE OF THE OXYGENATOR. TO CALCULATE THE GAS EXCHANGE PERFORMANCE, DATA ON VENOUS AND ARTERIAL SATURATION WOULD BE NEEDED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT PHYSICAL EXAMINATION OF THE ACTUAL DEVICE. THEREFORE, THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT UTILIZING THE XLUNG 230 KIT OXYGENATOR EXPERIENCED A FAILURE OF GAS EXCHANGE. THERE WAS AN INFERRED ALLEGATION THIS EVENT WAS DUE TO THE UNDERPERFORMANCE OF THE XLUNG 230 KIT IN THE INITIAL REPORTING. FURTHER REVIEW OF THE COMPLAINT INTAKE FORM UNCOVERED THE FOLLOWING. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED (DATE OF ADMISSION UNKNOWN) FOLLOWING A DIAGNOSIS OF COVID-19 WITH ACUTE RESPIRATORY DISTRESS SYNDROME AND IT WAS DETERMINED THE PATIENT REQUIRED ECMO SUPPORT ON (B)(6) 2021. ON (B)(6) 2021, IT WAS FOUND THE PERFORMANCE OF OXYGENATION AND REMOVAL OF CARBON DIOXIDE BY THE XLUNG 230 KIT WAS SUBOPTIMAL DESPITE A SWEEP GAS FLOW OF 10 L/MIN. DESPITE THE ALLEGED UNDERPERFORMANCE, ECMO SUPPORT CONTINUED WITH THE SAME OXYGENATOR FOR AN ADDITIONAL 8 DAYS. ON (B)(6) 2021, BLOOD GAS SAMPLING SHOWED A PRE-OXYGENATOR SATURATION OF ARTERIAL OXYGEN (SAO2) OF 32.6 MMHG AND A POST-OXYGENATOR SAO2 OF 115 MMHG. ADDITIONALLY, PRE-OXYGENATOR SATURATION OF ARTERIAL CARBON DIOXIDE (SACO2) PRESENTED 57.2 MMHG AND A POST-OXYGENATOR SACO2 OF 46.1 MMHG. AT THAT TIME, IT WAS DETERMINED TO EXCHANGE THE OXYGENATOR AND CONTINUE WITH ECMO SUPPORT. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING A SERIOUS INJURY OR ADVERSE EVENT AS A RESULT OF SUBOPTIMAL GAS EXCHANGE. MEDICAL INTERVENTION IN RESPONSE TO THIS EVENT INVOLVED EXCHANGING THE XLUNG 230 KIT; HOWEVER, THE XLUNG KIT 230 IS RATED FOR 9 DAYS OF CONTINUOUS USE AND AN EXCHANGE OF THE OXYGENATOR WAS APPROPRIATE THROUGH THE NORMAL COURSE OF ECMO SUPPORT. THE PRODUCT SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL REVIEW: IN REVIEW OF THE BLOOD GAS SAMPLING, THE RESULTS DEMONSTRATE ADEQUATE OXYGENATION AND CARBON DIOXIDE REMOVAL. THE EXPECTED RESULT WAS HYPEROXYGENATION OF THIS PATIENT, YET THE EVIDENCE SHOWS ECMO SUPPORT WAS SUFFICIENT IN GAS EXCHANGE AND DID NOT PRESENT A DELETERIOUS AFFECT TO THE PATIENT. THERE IS NO EVIDENCE OF ¿FAILURE¿ AS STATED IN THE INTAKE AS ECMO SUPPORT UTILIZING THE XLUNG 230 KIT. THIS IS FURTHER EVIDENCED BY THE CONTINUED USE OF THE OXYGENATOR AND THE APPROPRIATE EXCHANGE AT THE PRESCRIBED INTERVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT UTILIZING THE XLUNG 230 KIT OXYGENATOR EXPERIENCED A FAILURE OF GAS EXCHANGE. THERE WAS AN INFERRED ALLEGATION THIS EVENT WAS DUE TO THE UNDERPERFORMANCE OF THE XLUNG 230 KIT IN THE INITIAL REPORTING. FURTHER REVIEW OF THE COMPLAINT INTAKE FORM UNCOVERED THE FOLLOWING. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED (DATE OF ADMISSION UNKNOWN) FOLLOWING A DIAGNOSIS OF COVID-19 WITH ACUTE RESPIRATORY DISTRESS SYNDROME AND IT WAS DETERMINED THE PATIENT REQUIRED ECMO SUPPORT ON (B)(6) 2021. ON (B)(6) 2021, IT WAS FOUND THE PERFORMANCE OF OXYGENATION AND REMOVAL OF CARBON DIOXIDE BY THE XLUNG 230 KIT WAS SUBOPTIMAL DESPITE A SWEEP GAS FLOW OF 10 L/MIN. DESPITE THE ALLEGED UNDERPERFORMANCE, ECMO SUPPORT CONTINUED WITH THE SAME OXYGENATOR FOR AN ADDITIONAL 8 DAYS. ON (B)(6) 2021, BLOOD GAS SAMPLING SHOWED A PRE-OXYGENATOR SATURATION OF ARTERIAL OXYGEN (SAO2) OF 32.6 MMHG AND A POST-OXYGENATOR SAO2 OF 115 MMHG. ADDITIONALLY, PRE-OXYGENATOR SATURATION OF ARTERIAL CARBON DIOXIDE (SACO2) PRESENTED 57.2 MMHG AND A POST-OXYGENATOR SACO2 OF 46.1 MMHG. AT THAT TIME, IT WAS DETERMINED TO EXCHANGE THE OXYGENATOR AND CONTINUE WITH ECMO SUPPORT. THERE WAS NO REPORT OF THE PATIENT EXPERIENCING A SERIOUS INJURY OR ADVERSE EVENT AS A RESULT OF SUBOPTIMAL GAS EXCHANGE. MEDICAL INTERVENTION IN RESPONSE TO THIS EVENT INVOLVED EXCHANGING THE XLUNG 230 KIT; HOWEVER, THE XLUNG KIT 230 IS RATED FOR 9 DAYS OF CONTINUOUS USE AND AN EXCHANGE OF THE OXYGENATOR WAS APPROPRIATE THROUGH THE NORMAL COURSE OF ECMO SUPPORT. THE PRODUCT SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721602 XLUNG KIT 230 QJZ QJZ XENIOS AG 8013279

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention NOVALUNG CONSOLE| NOVALUNG CONSOLE