XLUNG KIT 230
Report
- Report Number
- 3012172416-2023-00088
- Event Type
- Malfunction
- Date Received
- November 9, 2023
- Date of Event
- October 16, 2023
- Report Date
- February 7, 2024
- Manufacturer
- XENIOS AG
- Product Code
- QJZ
- PMA / PMN Number
- K191407
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION: D4 PLANT INVESTIGATION: A COMPLAINT SAMPLE WAS NOT AVAILABLE FOR MANUFACTURER EVALUATION. THE PERFORMANCE OF THE GAS EXCHANGE IS INFLUENCED BY APPLICATION PARAMETERS LIKE ANTICOAGULATION, BLOOD FLOW AND SWEEP GAS FLOW. THE CAUSE MAY BE PATIENT INDUCED, AND IT IS HIGHLY UNLIKELY TO DETECT A FAILURE IN THE RETENTION SAMPLE. THE DESCRIBED SITUATION IS ADEQUATELY ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU) AND/OR ON THE LABEL. A REVIEW OF THE BATCH DOCUMENTATION WAS PERFORMED. NO NON-CONFORMITIES WERE OBSERVED DURING THE MANUFACTURING PROCESS. AS AN EVALUATION OF THE SAMPLE COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED ISSUE COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.
NOTE: THIS REPORT CAPTURES ONE OF THE TWO KITS THAT HAD TO BE REPLACED. AN ADDITIONAL REPORT IS BEING SUBMITTED FOR THE OTHER KIT; SEE MFR REPORT# 3012172416-2023-00089. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
A USER FACILITY REPORTED SUBOPTIMAL OXYGENATION LEVELS FROM TWO DIFFERENT XLUNG KITS DURING A PATIENT¿S EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY. THE PATIENT WAS PUT ON ECMO SUPPORT FOLLOWING THE CONCLUSION OF AN UNSPECIFIED TRANSPLANT SURGERY. THE PATIENT¿S OXYGENATION HAD NOT IMPROVED, AND THE PO2 CONTINUED TO DECREASE. AFTER INVESTIGATING ALL OTHER POSSIBLE ISSUES, THE ECMO TEAM SUSPECTED THERE WAS A PROBLEM WITH THE OXYGENATOR AND IMMEDIATELY REPLACED THE XLUNG KIT WITH ANOTHER ONE. AFTER REPLACING THE KIT, THE PATIENT¿S PO2 STILL DIDN¿T INCREASE AND THE TREATMENT HAD TO BE INTERRUPTED. THE TEAM DECIDED TO ¿REPLACE THE SOLIN MACHINE AND SOLIN OXYGENATOR¿ [SIC]. AFTER THE PATIENT¿S ECMO SUPPORT WAS RESTARTED ON THE NEW DEVICE, THEIR OXYGENATION LEVELS IMPROVED IMMEDIATELY. AS A RESULT, THE FACILITY DETERMINED THERE WAS AN ISSUE WITH THE TWO XENIOS XLUNG KITS. THE REPORTED EVENTS RESULTED IN APPROXIMATELY 500 ML (OR LESS) OF BLOOD LOSS. THE PATIENT WAS STILL ON ECMO SUPPORT AT THE TIME OF THE INITIAL REPORTING. THE SAMPLES WERE NOT REPORTED TO BE AVAILABLE FOR EVALUATION.
A USER FACILITY REPORTED SUBOPTIMAL OXYGENATION LEVELS FROM TWO DIFFERENT XLUNG KITS DURING A PATIENT¿S EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY. THE PATIENT WAS PUT ON ECMO SUPPORT FOLLOWING THE CONCLUSION OF AN UNSPECIFIED TRANSPLANT SURGERY. THE PATIENT¿S OXYGENATION HAD NOT IMPROVED, AND THE PO2 CONTINUED TO DECREASE. AFTER INVESTIGATING ALL OTHER POSSIBLE ISSUES, THE ECMO TEAM SUSPECTED THERE WAS A PROBLEM WITH THE OXYGENATOR AND IMMEDIATELY REPLACED THE XLUNG KIT WITH ANOTHER ONE. AFTER REPLACING THE KIT, THE PATIENT¿S PO2 STILL DIDN¿T INCREASE AND THE TREATMENT HAD TO BE INTERRUPTED. THE TEAM DECIDED TO ¿REPLACE THE SOLIN MACHINE AND SOLIN OXYGENATOR¿ [SIC]. AFTER THE PATIENT¿S ECMO SUPPORT WAS RESTARTED ON THE NEW DEVICE, THEIR OXYGENATION LEVELS IMPROVED IMMEDIATELY. AS A RESULT, THE FACILITY DETERMINED THERE WAS AN ISSUE WITH THE TWO XENIOS XLUNG KITS. THE REPORTED EVENTS RESULTED IN APPROXIMATELY 500 ML (OR LESS) OF BLOOD LOSS. THE PATIENT WAS STILL ON ECMO SUPPORT AT THE TIME OF THE INITIAL REPORTING. THE SAMPLES WERE NOT REPORTED TO BE AVAILABLE FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 92177 | XLUNG KIT 230 | EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATORY / CARDIOPULMONARY FAILURE | QJZ | XENIOS AG | 8016792 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | NOVALUNG CONSOLE| NOVALUNG CONSOLE |