XLUNG KIT 230

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4, H6 PLANT INVESTIGATION: THE DESCRIBED SITUATION IS ADEQUATELY ADDRESSED IN THE INSTRUCTIONS FOR USE AND/OR ON THE LABEL. DOCUMENTATION OF MODULE PRODUCTION REVEALED NO NON-CONFORMITY DURING THE MANUFACTURING PROCESS. THE TREND ANALYSIS SHOWED NO SIMILAR COMPLAINTS UNDER THE SAME BATCH NUMBER. AS THE COMPLAINT SAMPLE WAS UNAVAILABLE AND A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED. THE POTENTIAL CAUSES FOR LOW POST-OXYGENATOR ARTERIAL OXYGEN OR LOW OXYGENATOR PERFORMANCE CAN BE ATTRIBUTED TO THE PRODUCT AS WELL AS APPLICATION AND/OR PATIENT RELATED. A FAILURE IN THE GAS EXCHANGE FIBER COULD BE DUE TO A PROBLEM WITH RAW MATERIAL, FURTHER PROCESSING DURING MANUFACTURING OF THE OXYGENATOR. ADDITIONALLY, THE PERFORMANCE OF THE GAS EXCHANGER IS INFLUENCED BY APPLICATION PARAMETERS LIKE ANTICOAGULATION (ACT, APTT), BLOOD FLOW AND SWEEP GAS FLOW FRACTION OF INSPIRED OXYGEN. CLOTTING OF THE OXYGENATOR CAN NEGATIVELY IMPACT GAS EXCHANGE. ADDITIONALLY, HIGH BLOOD LEVELS OF FATS (HIGH SERUM LIPID LEVELS, E.G. AS A RESULT OF I.V. NUTRITION [WITH LIPIDS] OR SEDATION WITH PROPOFOL) OR HIGH FIBRINOGEN CAN LEAD TO SECONDARY MEMBRANE FORMATION IN THE OXYGENATOR WHICH MAY RESULT IN IMPAIRED GAS EXCHANGE. DUE TO THE INCREASED NUMBER OF COMPLAINTS DESCRIBING A LOW POST-OXYGENATOR ARTERIAL OXYGEN VALUE, A QUALITY EVENT WAS OPENED FOR FURTHER INVESTIGATION.

Description of Event or Problem

A USER FACILITY REPORTED, A PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT ON (B)(6) 2024 AT 00:15 (LOCAL). OXYGENATION WAS DETERMINED TO BE INADEQUATE. THE PARTIAL PRESSURE OF OXYGEN WAS LOW AT THE BEGINNING OF SUPPORT AND THE PHYSICIAN CHECKED THE [OXYGEN SOURCE] CONNECTIONS SO THE PROBLEM COULD BE ELIMINATED COMPLETELY. THE KIT HAD WAS REPLACED AT 11:30 (LOCAL) RESULTING IN A BLOOD LOSS APPROXIMATED AT 500 ML. THE PARTIAL PRESSURE OF OXYGEN INCREASED TO APPROXIMATELY 200 MMHG AFTER REPLACEMENT. THERE WAS NO INDICATION OF RESULTING INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT RETURN.

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, A PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT ON (B)(6) 2024 AT 00:15 (LOCAL). OXYGENATION WAS DETERMINED TO BE INADEQUATE. THE PARTIAL PRESSURE OF OXYGEN WAS LOW AT THE BEGINNING OF SUPPORT AND THE PHYSICIAN CHECKED THE [OXYGEN SOURCE] CONNECTIONS SO THE PROBLEM COULD BE ELIMINATED COMPLETELY. THE KIT HAD WAS REPLACED AT 11:30 (LOCAL) RESULTING IN A BLOOD LOSS APPROXIMATED AT 500 ML. THE PARTIAL PRESSURE OF OXYGEN INCREASED BY 200 MMHG AFTER REPLACEMENT. THERE WAS NO INDICATION OF RESULTING INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT RETURN.