XLUNG KIT 230

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4 H6 NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. THE PERFORMANCE TEST FOR GAS EXCHANGE WAS WITHIN SPECIFICATIONS. FOUR SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. AS A PHYSICAL EVALUATION COULD NOT BE CARRIED OUT, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED. THE CAUSE OF A LOW POST-OXYGENATOR PARTIAL OXYGEN PRESSURE (PAO2) OR LOW OXYGENATOR PERFORMANCE CAN BE PRODUCT AS WELL AS APPLICATION/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, SWEEP GAS FLOW AND 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 INTRAVENOUS 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 PO2 VALUE, A QUALITY EVENT WAS PREVIOUSLY OPENED FOR FURTHER INVESTIGATION.

Description of Event or Problem

A USER FACILITY REPORTED INADEQUATE OXYGENATION DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE PATIENT CIRCUIT WAS EXCHANGED RESULTING IN A BLOOD LOSS OF APPROXIMATELY 500 ML. UPON FOLLOW-UP, IT WAS REPORTED THE PATIENT'S ANTICOAGULATION PROTOCOL INVOLVED HEPARIN, RESULTING IN CLOTTING TIMES OF 50 TO 70 SECONDS. THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE PATIENT REMAINED ON ECMO SUPPORT AT THE TIME OF FOLLOW-UP. A COMPANION SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION; HOWEVER, NO PRODUCT WAS RETURNED.

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 INADEQUATE OXYGENATION DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE PATIENT CIRCUIT WAS EXCHANGED RESULTING IN A BLOOD LOSS OF APPROXIMATELY 500 ML. THERE WAS NO SPECIFIED RESULTING PATIENT INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.