XLUNG KIT (USA)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D9, H3. PLANT INVESTIGATION: THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. NO RETENTION SAMPLE ANALYSIS WAS PERFORMED SINCE THE LOT OF THE PRODUCT WAS UNKNOWN. 10 SIMILAR COMPLAINTS HAVE BEEN REPORTED IN 24 MONTHS. AS NO FURTHER INFORMATION WAS PROVIDED CONCERNING THE COMPLAINT SAMPLE, NO FINDINGS WERE AVAILABLE AND A CAUSE OF THIS EVENT COULD NOT BE ESTABLISHED.

Description of Event or Problem

A USER FACILITY REPORTED THAT THE P3 INTEGRATED SENSOR WAS NOT WORKING ON THE XLUNG KIT (USA) CIRCUIT. THE SENSOR DID NOT LIGHT UP GREEN ON THE CONSOLE DURING PRIMING AND READ NO PRESSURE DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. THE ECMO SPECIALIST HAD NO TIME TO CHANGE ANYTHING AS CANNULATION OCCURRED WITHIN 7 MINUTES. THE USER ADDED AN EXTERNAL PRESSURE SENSOR TO P3 AND THE CIRCUIT WAS STILL IN USE ON THE PATIENT. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT EVALUATION.

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 THE P3 INTEGRATED SENSOR WAS NOT WORKING ON THE XLUNG KIT (USA) CIRCUIT. THE SENSOR DID NOT LIGHT UP GREEN ON THE CONSOLE DURING PRIMING AND READ NO PRESSURE DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. THE ECMO SPECIALIST HAD NO TIME TO CHANGE ANYTHING AS CANNULATION OCCURRED WITHIN 7 MINUTES. THE USER ADDED AN EXTERNAL PRESSURE SENSOR TO P3 AND THE CIRCUIT WAS STILL IN USE ON THE PATIENT. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE IS ANTICIPATED FOR PRODUCT EVALUATION ONCE DISCONTINUED FROM PATIENT SUPPORT.