XLUNG KIT 230

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: SECTION A (PATIENT AGE), B5, D4 PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. TWO SIMILAR COMPLAINTS HAS BEEN REPORTED ABOUT THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A FAILURE IN THE GAS-EXCHANGE FIBER COULD BE DUE TO A PROBLEM WITH RAW MATERIAL OR 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/OR 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.

Description of Event or Problem

A USER FACILITY REPORTED OXYGENATION WAS INADEQUATE AT THE BEGINNING OF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. THE PATIENT WAS PLACED ON SUPPORT FOLLOWING MULTIPLE INJURIES, SHOCK, LOW OXYGEN SATURATION AND PULMONARY EMBOLISM. ARTERIAL OXYGENATION PRIOR TO SUPPORT WAS 50.6 MMHG AND 169.8 MMHG SHORTLY AFTER THE INITIATION OF SUPPORT. THE USER REPORTED THAT AFTER CORRECTING A "CONNECTION", THE PROBLEM WAS ELIMINATED AND THE PATIENT CONTINUED SUPPORT WITH THE SAME XLUNG KIT 230. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.

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 OXYGENATION WAS INADEQUATE AT THE BEGINNING OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO SPECIFIED PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION.