XLUNG KIT 230
Report
- Report Number
- 3012172416-2021-00018
- Event Type
- Injury
- Date Received
- May 18, 2021
- Date of Event
- April 23, 2021
- Report Date
- August 11, 2021
- Manufacturer
- XENIOS AG
- Product Code
- QJZ
- PMA / PMN Number
- K191407
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PLANT INVESTIGATION: THE SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, AND THREE BLOOD GAS ANALYSES WERE PROVIDED VIA EMAIL. NO ABNORMALITIES WERE OBSERVED ON THE PRODUCT DURING VISUAL EXAMINATION. THE REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE XLUNG KIT BATCH AND OXYGENATOR DID NOT REVEAL ANY ANOMALIES OR DEVIATIONS. SIMILAR CASES FROM THE PREVIOUS 24 MONTHS WERE REVIEWED, AND NO PRODUCT RELATED ISSUES WERE CONFIRMED IN ANY OF THEM. REVIEW OF THE PROVIDED DATA REVEALED THAT ONLY THE POST-OXYGENATION BLOOD GASES WERE PROVIDED, AND THUS, A PRECISE CALCULATION OF OXYGEN TRANSFER PERFORMANCE WAS NOT POSSIBLE. TO PERFORM A FULL EVALUATION OF THE OXYGEN TRANSFER PERFORMANCE DURING TREATMENT, THE INPUT BLOOD GASES OF THE OXYGENATOR WOULD BE NEEDED, AND THIS INFORMATION WAS NOT PROVIDED. THE REASON FOR THE COMPARATIVELY LOW PO2 VALUES MAY HAVE BEEN CAUSED BY PATIENT-RELATED INFLUENCES. THE PERFORMANCE OF THE RETURNED PRODUCT SAMPLE WAS TESTED FOR GAS EXCHANGE. THE PRODUCT PERFORMED WITHIN ITS SPECIFICATION AND THE MEASURED GAS EXCHANGE WAS FOUND TO BE ABOVE THE THRESHOLD VALUES. UPON COMPLETION OF THE EVALUATION, A PRODUCT RELATED ISSUE COULD NOT BE CONFIRMED AS THERE WERE NO DEFICIENCIES FOUND DURING EXAMINATION. THE PERFORMANCE TEST SHOWED THAT THE OXYGENATOR WAS WITHIN PRODUCT SPECIFICATION FOR THE GAS TRANSFER.
THOUGH PRODUCTION AND DEVICE HISTORY RECORD (DHR) REVIEWS WERE COMPLETED, THE PLANT INVESTIGATION IS STILL IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. PLANT INVESTIGATION: A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS.
IT WAS REPORTED TO FRESENIUS THAT A PATIENT ON VENO-VENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT ON THE NOVALUNG ECMO DEVICE UTILIZING THE XLUNG 230 OXYGENATOR EXPERIENCED SUB-OPTIMAL OXYGENATION. THERE WAS AN INFERRED ALLEGATION THIS EVENT WAS DUE TO THE UNDERPERFORMANCE OF THE XLUNG 230 KIT. UPON FURTHER REVIEW OF THE COMPLAINT INTAKE INFORMATION, IT WAS REPORTED THIS PATIENT WAS HOSPITALIZED (ADMISSION DATE UNKNOWN) FOR PULMONARY FAILURE DUE TO A COVID-19 INFECTION. THE DECISION WAS MADE TO PLACE THE PATIENT ON ECMO SUPPORT UTILIZING A CARDIOHELP DEVICE (NOT A FRESENIUS PRODUCT, DATE UNKNOWN). ON (B)(6) 2021, THE PATIENT WAS TRANSITIONED TO THE NOVALUNG CONSOLE UTILIZING THE XLUNG 230 OXYGENATOR. THE ECMO SETTINGS INCLUDED A BLOOD FLOW OF 5.5 L/MIN WITH A SWEEP GAS OF 10 L/MIN OF 100% OXYGEN. IT WAS FOUND THE PATIENT HAD SUB-OPTIMAL OXYGENATION WITH A PERIPHERAL OXYGEN SATURATION (SPO2) OF 86% AND POST-OXYGENATOR BLOOD SAMPLING THAT PRESENTED A SATURATION OF ARTERIAL OXYGEN (PAO2) OF 136 MMHG. THE SWEEP GAS WAS DECREASED TO 9 L/MIN FOLLOW THE LABORATORY RESULTS. THE NEXT POST-OXYGENATOR PAO2 TAKEN 25 MINUTES LATER PRESENTED 89 MMHG WHICH PROMPTED A DECREASE OF BLOOD FLOW TO 4.5 L/MIN. AFTER 15 MINUTES, A FINAL POST-OXYGENATOR PAO2 PRESENTED WITH 117 AND THE DECISION WAS MADE TO TRANSITION THE PATIENT TO THE CARDIOHELP DEVICE THAT PRESENTED A POST-OXYGENATOR PAO2 OF 350 MMHG AND AN SPO2 IN THE MID-90¿S. THERE WAS NO REPORT THE PATIENT EXPERIENCED A SERIOUS INJURY OR ADVERSE EVENT AS A RESULT OF SUB-OPTIMAL GAS EXCHANGE. MEDICAL INTERVENTION IN RESPONSE TO THIS EVENT INVOLVED TRANSITIONING THE PATIENT TO A DIFFERENT BRAND OF ECMO DEVICE AND OXYGENATOR. THE PRODUCT SAMPLE WAS REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION.
IT WAS REPORTED TO FRESENIUS THAT A PATIENT ON VENO-VENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT ON THE NOVALUNG ECMO DEVICE UTILIZING THE XLUNG 230 OXYGENATOR EXPERIENCED SUB-OPTIMAL OXYGENATION. THERE WAS AN INFERRED ALLEGATION THIS EVENT WAS DUE TO THE UNDERPERFORMANCE OF THE XLUNG 230 KIT. UPON FURTHER REVIEW OF THE COMPLAINT INTAKE INFORMATION, IT WAS REPORTED THIS PATIENT WAS HOSPITALIZED (ADMISSION DATE UNKNOWN) FOR PULMONARY FAILURE DUE TO A COVID-19 INFECTION. THE DECISION WAS MADE TO PLACE THE PATIENT ON ECMO SUPPORT UTILIZING A CARDIOHELP DEVICE (NOT A FRESENIUS PRODUCT, DATE UNKNOWN). ON (B)(6) 2021, THE PATIENT WAS TRANSITIONED TO THE NOVALUNG CONSOLE UTILIZING THE XLUNG 230 OXYGENATOR. THE ECMO SETTINGS INCLUDED A BLOOD FLOW OF 5.5 L/MIN WITH A SWEEP GAS OF 10 L/MIN OF 100% OXYGEN. IT WAS FOUND THE PATIENT HAD SUB-OPTIMAL OXYGENATION WITH A PERIPHERAL OXYGEN SATURATION (SPO2) OF 86% AND POST-OXYGENATOR BLOOD SAMPLING THAT PRESENTED A SATURATION OF ARTERIAL OXYGEN (PAO2) OF 136 MMHG. THE SWEEP GAS WAS DECREASED TO 9 L/MIN FOLLOW THE LABORATORY RESULTS. THE NEXT POST-OXYGENATOR PAO2 TAKEN 25 MINUTES LATER PRESENTED 89 MMHG WHICH PROMPTED A DECREASE OF BLOOD FLOW TO 4.5 L/MIN. AFTER 15 MINUTES, A FINAL POST-OXYGENATOR PAO2 PRESENTED WITH 117 AND THE DECISION WAS MADE TO TRANSITION THE PATIENT TO THE CARDIOHELP DEVICE THAT PRESENTED A POST-OXYGENATOR PAO2 OF 350 MMHG AND AN SPO2 IN THE MID-90¿S. THERE WAS NO REPORT THE PATIENT EXPERIENCED A SERIOUS INJURY OR ADVERSE EVENT AS A RESULT OF SUB-OPTIMAL GAS EXCHANGE. MEDICAL INTERVENTION IN RESPONSE TO THIS EVENT INVOLVED TRANSITIONING THE PATIENT TO A DIFFERENT BRAND OF ECMO DEVICE AND OXYGENATOR. THE PRODUCT SAMPLE WAS REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION.
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 EFFECT TO THE PATIENT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF A SERIOUS INJURY, PATIENT DEATH, OR OTHER ADVERSE EVENT RELATED TO A FRESENIUS PRODUCT OR OTHER ISSUE WARRANTING FURTHER INVESTIGATION.
IT WAS REPORTED TO FRESENIUS THAT A PATIENT ON VENO-VENOUS (VV) EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT ON THE NOVALUNG ECMO DEVICE UTILIZING THE XLUNG 230 OXYGENATOR EXPERIENCED SUB-OPTIMAL OXYGENATION. THERE WAS AN INFERRED ALLEGATION THIS EVENT WAS DUE TO THE UNDERPERFORMANCE OF THE XLUNG 230 KIT. UPON FURTHER REVIEW OF THE COMPLAINT INTAKE INFORMATION, IT WAS REPORTED THIS PATIENT WAS HOSPITALIZED (ADMISSION DATE UNKNOWN) FOR PULMONARY FAILURE DUE TO A COVID-19 INFECTION. THE DECISION WAS MADE TO PLACE THE PATIENT ON ECMO SUPPORT UTILIZING A CARDIOHELP DEVICE (NOT A FRESENIUS PRODUCT, DATE UNKNOWN). ON (B)(6) 2021, THE PATIENT WAS TRANSITIONED TO THE NOVALUNG CONSOLE UTILIZING THE XLUNG 230 OXYGENATOR. THE ECMO SETTINGS INCLUDED A BLOOD FLOW OF 5.5 L/MIN WITH A SWEEP GAS OF 10 L/MIN OF 100% OXYGEN. IT WAS FOUND THE PATIENT HAD SUB-OPTIMAL OXYGENATION WITH A PERIPHERAL OXYGEN SATURATION (SPO2) OF 86% AND POST-OXYGENATOR BLOOD SAMPLING THAT PRESENTED A SATURATION OF ARTERIAL OXYGEN (PAO2) OF 136 MMHG. THE SWEEP GAS WAS DECREASED TO 9 L/MIN FOLLOW THE LABORATORY RESULTS. THE NEXT POST-OXYGENATOR PAO2 TAKEN 25 MINUTES LATER PRESENTED 89 MMHG WHICH PROMPTED A DECREASE OF BLOOD FLOW TO 4.5 L/MIN. AFTER 15 MINUTES, A FINAL POST-OXYGENATOR PAO2 PRESENTED WITH 117 AND THE DECISION WAS MADE TO TRANSITION THE PATIENT TO THE CARDIOHELP DEVICE THAT PRESENTED A POST-OXYGENATOR PAO2 OF 350 MMHG AND AN SPO2 IN THE MID-90¿S. THERE WAS NO REPORT THE PATIENT EXPERIENCED A SERIOUS INJURY OR ADVERSE EVENT AS A RESULT OF SUB-OPTIMAL GAS EXCHANGE. MEDICAL INTERVENTION IN RESPONSE TO THIS EVENT INVOLVED TRANSITIONING THE PATIENT TO A DIFFERENT BRAND OF ECMO DEVICE AND OXYGENATOR. THE PRODUCT SAMPLE WAS REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 736454 | XLUNG KIT 230 | QJZ | QJZ | XENIOS AG | 8013156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention | NOVALUNG CONSOLE| NOVALUNG CONSOLE| NOVALUNG CONSOLE| NOVALUNG CONSOLE |