XLUNG KIT 230

Description of Event or Problem

A USER FACILITY REPORTED THAT SHORTLY AFTER STARTING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THE PATIENT'S POST-OXYGENATOR ARTERIAL OXYGEN (PAO2) WAS 300 MMHG. FOLLOWING 24 HOURS AFTER STARTING SUPPORT, IT WAS 70 MMHG. THE XLUNG KIT WAS EXCHANGED BY THE USER. THE SECOND XLUNG KIT HAD THE SAME ISSUE. THE PATIENT WAS TRANSITIONED TO A COMPETITOR PRODUCT FOR CONTINUED SUPPORT. THE PATIENT HAD INFLUENZA AND MRSA. BEFORE THE USE OF THIS KIT, THREE OTHERS WERE USED ON THIS PATIENT OVER THE COURSE OF 5 DAYS. THE OTHER THREE KITS MAINTAINED A PAO2 OF 280-330 MMHG DURING SUPPORT. AFTER A WEEK FOLLOWING THE INCIDENT, THE PATIENT UNDERWENT AN MRI TO CHECK FOR BRAIN DAMAGE DUE TO LOW OXYGENATION WHERE NONE WAS FOUND. IT WAS BELIEVED THAT THE PATIENT RECOVERED FROM THIS EVENT. THE OXYGENATOR ALONE IS BEING RETURNED FOR PRODUCT EVALUATION, AND THE REST OF THE KIT WAS DISCARDED. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY.

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 SHORTLY AFTER STARTING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT, THE PATIENT¿S POST-OXYGENATOR ARTERIAL OXYGEN (PAO2) WAS 300 MMHG. FOLLOWING 24 HOURS AFTER STARTING SUPPORT, IT WAS 70 MMHG. THE XLUNG KIT WAS EXCHANGED BY THE USER. THE SECOND XLUNG KIT HAD THE SAME ISSUE. THE PATIENT WAS TRANSITIONED TO A COMPETITOR PRODUCT FOR CONTINUED SUPPORT. THE PATIENT HAD INFLUENZA AND MRSA. BEFORE THE USE OF THIS KIT, THREE OTHERS WERE USED ON THIS PATIENT OVER THE COURSE OF 5 DAYS. THE OTHER THREE KITS MAINTAINED A PAO2 OF 280-330 MMHG DURING SUPPORT. AFTER A WEEK FOLLOWING THE INCIDENT, THE PATIENT UNDERWENT AN MRI TO CHECK FOR BRAIN DAMAGE DUE TO LOW OXYGENATION WHERE NONE WAS FOUND. IT WAS BELIEVED THAT THE PATIENT RECOVERED FROM THIS EVENT. THERE WAS NO INDICATION OF PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT RETURNED BY THE USER FACILITY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D4, D9, H3 PLANT INVESTIGATION: NO NON-CONFORMITY WAS OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER SIMILAR COMPLAINT HAS BEEN REPORTED CONCERNING 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 FRACTION OF INSPIRED OXYGEN. AS A PRODUCT INVESTIGATION COULD NOT BE CARRIED OUT, A DEFINITIVE CAUSE FOR THE REPORTED SUBOPTIMAL OXYGENATION LEVELS COULD NOT BE DETERMINED.