XLUNG KIT (USA)
Report
- Report Number
- 3012172416-2023-00065
- Event Type
- Malfunction
- Date Received
- August 7, 2023
- Date of Event
- July 5, 2023
- Report Date
- November 15, 2023
- Manufacturer
- XENIOS AG
- Product Code
- QJZ
- UDI-DI
- 04057224902043
- PMA / PMN Number
- K191407
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION: D4 NOTE: A SEPARATE MDR WAS SUBMITTED FOR THE CLOTTING EVENT FROM (B)(6) 2023; SEE MFR REPORT #: 3012172416-2023-00066. PLANT INVESTIGATION: NO SAMPLE WAS RETURNED FOR EVALUATION. SINCE THE CAUSE WAS PRESUMABLY PATIENT INDUCED, IT IS HIGHLY UNLIKELY TO DETECT A FAILURE IN A RETENTION SAMPLE. A REVIEW OF THE BATCH DOCUMENTATION WAS PERFORMED. THERE WERE FOUR QUALITY EVENTS (QES) FOR THE BATCH. HOWEVER, THREE OF THE QES WERE NOT RELATED TO THE DESCRIBED ISSUE. ONE OF THE QES IS REFERRING TO A FAILED GAS PERFORMANCE TEST OF ONE TEST SAMPLE OUT OF THE BATCH. 13 XLUNG KITS WERE TESTED, AND 1 OF 13 SAMPLES FAILED THE TEST. THE NON-CONFORMANCE OF ONE FAILED TEST SAMPLE IS CONSIDERED A SINGLE CASE ISSUE. THE SINGLE CASE DEVIATION WAS ASSESSED AS A MARGINAL DEVIATION OF LESS THAN 5% OF THE SPECIFIED GAS PERFORMANCE. A TEST WITH ANOTHER 13 SAMPLES YIELDED CONFORMING RESULTS OF ALL 13 SAMPLES. THE DESCRIBED SITUATION IS ADEQUATELY ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU) AND/OR ON THE LABEL. TYPICAL XLUNG KIT GAS TRANSFER RATES ARE GIVEN IN THE IFU. ACCORDING TO THE PERFORMANCE DATA, THE OXYGEN TRANSFER RATE AT A BLOOD FLOW OF 3 L/MIN SHOULD BE AROUND 200 ML/MIN. BASED ON THE PROVIDED INFORMATION, THE OXYGEN TRANSFER RATE DURING THE THERAPY MAY HAVE BEEN SLIGHTLY BELOW THIS VALUE. HOWEVER, SINCE A PHYSICAL EVALUATION OF THE OXYGENATOR COULD NOT BE PERFORMED, A DEFINITIVE CAUSE FOR THE EVENT COULD NOT BE CONFIRMED.
THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.
IT WAS REPORTED THAT A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY EXPERIENCED SUBOPTIMAL OXYGENATION LEVELS DURING THE USE OF A XENIOS XLUNG KIT. ON (B)(6) 2023, AT 2:08 LOCAL TIME, THE PRE PO2/SAT WAS 36 MMHG/55.8%, AND THE POST PO2/SAT WAS 70 MMHG/92.2%. AT 3:12 LOCAL TIME, THE POST PO2/SAT REMAINED LOW AT 69 MMHG/94.9%. THE FOLLOWING DAY, THE FACILITY MADE THE DECISION TO CUT OUT THE OXYGENATOR FROM THE KIT AND REPLACE IT WITH A NAUTILUS OXYGENATOR (NOT A FRESENIUS/XENIOS PRODUCT). REPLACING THE OXYGENATOR RESULTED IN APPROXIMATELY 320 ML OF BLOOD LOSS. THE PATIENT¿S ECMO SETTINGS WERE AS FOLLOWS: 3 LITERS PER MINUTE (LPM) BLOOD FLOW AT 7300 REVOLUTIONS PER MINUTE (RPM)S, WITH A SWEEP GAS FLOW OF 4 LPM. THE PATIENT WAS PUT ON ECMO THERAPY AFTER EXPERIENCING AN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) / PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST, AND DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) HAD MULTIPLE EPISODES OF VENTRICULAR TACHYCARDIA WITH ARREST. THE PATIENT HAD HEMODYNAMIC AND CARDIAC INSTABILITY. THE PATIENT WAS PLACED ON HEPARIN FOR ANTICOAGULATION. THE ACT LEVEL WAS NOT REPORTED, AND NO CLOTS WERE NOTICED IN THE KIT OR OXYGENATOR. AFTER CHANGING TO THE NAUTILUS OXYGENATOR, POST PO2/SAT LEVELS INCREASED TO >500 MMHG/100%. THE ENTIRE CIRCUIT WAS LATER CHANGED OUT ON (B)(6) 2023 DUE TO CLOTTING IN THE PUMP HEAD. THE PATIENT WAS SUCCESSFULLY WEANED FROM THERAPY THE FOLLOWING DAY. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.
IT WAS REPORTED THAT A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY EXPERIENCED SUBOPTIMAL OXYGENATION LEVELS DURING THE USE OF A XENIOS XLUNG KIT. ON (B)(6) 2023, AT 2:08 LOCAL TIME, THE PRE PO2/SAT WAS 36 MMHG/55.8%, AND THE POST PO2/SAT WAS 70 MMHG/92.2%. AT 3:12 LOCAL TIME, THE POST PO2/SAT REMAINED LOW AT 69 MMHG/94.9%. THE FOLLOWING DAY, THE FACILITY MADE THE DECISION TO CUT OUT THE OXYGENATOR FROM THE KIT AND REPLACE IT WITH A NAUTILUS OXYGENATOR (NOT A FRESENIUS/XENIOS PRODUCT). REPLACING THE OXYGENATOR RESULTED IN APPROXIMATELY 320 ML OF BLOOD LOSS. THE PATIENT¿S ECMO SETTINGS WERE AS FOLLOWS: 3 LITERS PER MINUTE (LPM) BLOOD FLOW AT 7300 REVOLUTIONS PER MINUTE (RPM)S, WITH A SWEEP GAS FLOW OF 4 LPM. THE PATIENT WAS PUT ON ECMO THERAPY AFTER EXPERIENCING AN ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) / PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST, AND DURING PERCUTANEOUS CORONARY INTERVENTION (PCI) HAD MULTIPLE EPISODES OF VENTRICULAR TACHYCARDIA WITH ARREST. THE PATIENT HAD HEMODYNAMIC AND CARDIAC INSTABILITY. THE PATIENT WAS PLACED ON HEPARIN FOR ANTICOAGULATION. THE ACT LEVEL WAS NOT REPORTED, AND NO CLOTS WERE NOTICED IN THE KIT OR OXYGENATOR. AFTER CHANGING TO THE NAUTILUS OXYGENATOR, POST PO2/SAT LEVELS INCREASED TO >500 MMHG/100%. THE ENTIRE CIRCUIT WAS LATER CHANGED OUT ON (B)(6) 2023 DUE TO CLOTTING IN THE PUMP HEAD. THE PATIENT WAS SUCCESSFULLY WEANED FROM THERAPY THE FOLLOWING DAY. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1457600 | XLUNG KIT (USA) | EXTRACORPOREAL SYSTEM FOR LONG-TERM RESPIRATORY / CARDIOPULMONARY FAILURE | QJZ | XENIOS AG | 8015860 | 04057224902043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | NOVALUNG CONSOLE.| NOVALUNG CONSOLE. |