XLUNG KIT 230

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 FOLLOWING RESUSCITATION AFTER A CARDIAC ARREST, ATTRIBUTED TO AN ACUTE MYOCARDIAL INFARCTION. THE PARTIAL PRESSURE OF OXYGEN (PAO2) OF THE POST-OXYGENATOR SAMPLE WAS 53.4 MMHG BEFORE ECMO SUPPORT START AND REMAINED AT 53.41 MMHG AFTER 30 MINUTES OF SUPPORT. THE PHYSICIAN TRIED TO INCREASE GAS FLOW TO 8L/MIN WITH NO IMPROVEMENT. UPON FOLLOW-UP, IT WAS REPORTED THE KIT WAS EXCHANGED WHICH PRODUCED A PAO2 OF 77 MMHG AND RESULTED IN A BLOOD LOSS OF APPROXIMATELY 500 ML. THERE WAS NO INDICATION OF RESULTING SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D3, D4, G1, H6. PLANT INVESTIGATION: NO NONCONFORMITY WAS OBSERVED DURING THE MANUFACTURING PROCESS. ONE OTHER COMPLAINT WITH THE SAME FAILURE PATTERN HAS BEEN REPORTED FOR THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THE ECMO SETTINGS SUGGEST AN APPROPRIATE SETUP, WITH A BLOOD FLOW OF 2.7 L/MIN, SWEEP GAS FLOW AT 3 L/MIN, AND FIO2 AT 100%. DESPITE THIS, THE OBSERVED LOW POST-OXYGENATOR ARTERIAL OXYGEN (47 MMHG) AND LOW SATURATION OF OXYGEN (79%) INDICATE INSUFFICIENT GAS EXCHANGE ACROSS THE MEMBRANE. WHILE THE GAS EXCHANGE PERFORMANCE OF THE OXYGENATOR CANNOT BE EVALUATED AS NO PRE-OXYGENATOR VALUES WERE PROVIDED, THE IMPROVED VALUES OF THE PATIENT¿S ARTERIAL OXYGEN AFTER THE REPLACEMENT (TO 77 MMHG) AND SATURATION OF OXYGEN (TO 100%), SUGGEST THAT THE INITIAL OXYGENATOR WAS NOT FUNCTIONING AS INTENDED. A FAILURE IN THE GAS EXCHANGE FIBER COULD BE DUE TO A PROBLEM WITH RAW MATERIAL OR FURTHER PROCESSING DURING THE MANUFACTURING OF THE OXYGENATOR. ADDITIONALLY, THE PERFORMANCE OF THE GAS EXCHANGER IS INFLUENCED BY APPLICATION PARAMETERS LIKE ANTICOAGULATION (ACT, APTT), BLOOD AND 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. THE COMPLAINT DATA WAS RECORDED STATISTICALLY, AND WE ARE MONITORING THE MARKET FOR THE OCCURRENCE OF SIMILAR CASES.

Description of Event or Problem

A USER FACILITY REPORTED A PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT FOLLOWING RESUSCITATION AFTER A CARDIAC ARREST, ATTRIBUTED TO AN ACUTE MYOCARDIAL INFARCTION. THE PARTIAL PRESSURE OF OXYGEN (PAO2) OF THE POST-OXYGENATOR SAMPLE WAS 53.4 MMHG BEFORE ECMO SUPPORT START AND REMAINED AT 53.41 MMHG AFTER 30 MINUTES OF SUPPORT. THE PHYSICIAN TRIED TO INCREASE GAS FLOW TO 8L/MIN WITH NO IMPROVEMENT. UPON FOLLOW-UP, IT WAS REPORTED THE KIT WAS EXCHANGED WHICH PRODUCED A PAO2 OF 77 MMHG AND RESULTED IN A BLOOD LOSS OF APPROXIMATELY 500 ML. THERE WAS NO INDICATION OF RESULTING SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.