XLUNG KIT 230

Description of Event or Problem

A USER FACILITY REPORTED THAT AT 14:00 (ALL TIMES LOCAL) ON (B)(6) 2026, PRESSURES INCREASED DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT FOR A PATIENT WITH RESPIRATORY SYNCYTIAL VIRUS. THE PATIENT KIT AND CONSOLE WERE EXCHANGED. BETWEEN 18:00 AND MIDNIGHT ON THE SAME DAY, SEVERAL BLOOD GASES SHOWED A DECLINE OF OXYGENATION SATURATION FROM 180 MMHG. THE FOLLOWING SATURDAY AROUND NOON (B)(6) 2026, THE KIT GAVE UNUSUAL NOISES AND SUBOPTIMAL ARTERIAL OXYGEN SATURATION CONTINUED. AT APPROXIMATELY 14:30 ON THE SAME DAY, THE DECISION FOR AN ADDITIONAL KIT EXCHANGE WAS MADE. THE PATIENT'S SUPPORT CONTINUED WITHOUT ISSUES FOLLOWING KIT EXCHANGE. THE PATIENT HAD A TOTAL BLOOD LOSS OF APPROXIMATELY 500 ML DUE TO KIT EXCHANGE. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED BY XENIOS FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: A3, B5, D9 THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A USER FACILITY REPORTED THAT AT 14:00 (ALL TIMES LOCAL) ON (B)(6) 2026, PRESSURES INCREASED DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT FOR A PATIENT WITH RESPIRATORY SYNCYTIAL VIRUS. THE PATIENT KIT AND CONSOLE WERE EXCHANGED. BETWEEN 18:00 AND MIDNIGHT ON THE SAME DAY, SEVERAL BLOOD GASES SHOWED A DECLINE OF OXYGENATION SATURATION FROM 180 MMHG. THE FOLLOWING SATURDAY AROUND NOON (ON (B)(6) 2026) THE KIT GAVE UNUSUAL NOISES AND SUBOPTIMAL ARTERIAL OXYGEN SATURATION CONTINUED. AT APPROXIMATELY 14:30 ON THE SAME DAY, THE DECISION FOR AN ADDITIONAL KIT EXCHANGE WAS MADE. THE PATIENT'S SUPPORT CONTINUED WITHOUT ISSUES FOLLOWING KIT EXCHANGE. THE PATIENT HAD A TOTAL BLOOD LOSS OF APPROXIMATELY 500 ML DUE TO KIT EXCHANGE. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4, H3 PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER SIMILAR COMPLAINTS HAVE BEEN REPORTED ABOUT THIS BATCH NUMBER. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND RECEIVED ON FEBRUARY 12, 2026. IT ARRIVED RINSED AND REMAINING VISIBLE RESIDUES OF RINSING FLUID MIXED WITH BLOOD COULD BE REMOVED BY RINSING THE OXYGENATOR. NO VISIBLE EXTERNAL DEFECTS WERE DETECTED ON THE KIT OR OXYGENATOR. TESTING OF THE GAS EXCHANGE PERFORMANCE SHOWED THAT THE OXYGEN TRANSFER RATE WAS 39 ML/MIN (LIMIT: 36 ML/MIN). AND THE MEASURED TRANSFER RATE FOR CO2 WAS 111 ML/MIN (LIMIT 111 ML/MIN). THE MEASURED GAS EXCHANGE PERFORMANCE MEETS THE ACCEPTANCE CRITERIA. AS THE PERFORMANCE TEST SHOWED THAT THE GAS TRANSFER RATE OF THE OXYGENATOR WAS WITHIN SPECIFICATION, A DEFINITIVE CAUSE FOR THE REPORTED LOW ARTERIAL OXYGEN LEVELS COULD NOT BE DETERMINED. THE REPORTED POST-OXYGENATOR ARTERIAL OXYGEN VALUES CAN BE INFLUENCED BY MULTIPLE CLINICAL AND OPERATIONAL FACTORS UNRELATED TO DEVICE, WHICH MAY INCLUDE ECMO OPERATIONAL SETTINGS AND PROGRESSIVE CLOT BURDEN OR PROTEIN DEPOSITION WITHIN THE CIRCUIT OVER TIME.

Description of Event or Problem

A USER FACILITY REPORTED THAT AT 14:00 (ALL TIMES LOCAL) ON (B)(6) 2026, PRESSURES INCREASED DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT FOR A PATIENT WITH RESPIRATORY SYNCYTIAL VIRUS. THE PATIENT KIT AND CONSOLE WERE EXCHANGED. BETWEEN 18:00 AND MIDNIGHT ON THE SAME DAY, SEVERAL BLOOD GASES SHOWED A DECLINE OF OXYGENATION SATURATION FROM 180 MMHG. THE FOLLOWING SATURDAY AROUND NOON (B)(6) 2026 THE KIT GAVE UNUSUAL NOISES AND SUBOPTIMAL ARTERIAL OXYGEN SATURATION CONTINUED. AT APPROXIMATELY 14:30 ON THE SAME DAY, THE DECISION FOR AN ADDITIONAL KIT EXCHANGE WAS MADE. THE PATIENT'S SUPPORT CONTINUED WITHOUT ISSUES FOLLOWING KIT EXCHANGE. THE PATIENT HAD A TOTAL BLOOD LOSS OF APPROXIMATELY 500 ML DUE TO KIT EXCHANGE. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED BY XENIOS FOR PRODUCT EVALUATION.