XLUNG KIT (USA)

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B5, D9 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 THEY HAD PREPARED A NOVALUNG CIRCUIT IN ANTICIPATION OF RECEIVING A PATIENT. FOLLOWING PRIMING, MEDICATIONS WERE ADDED TO THE CIRCUIT AND THE PUMP WAS RUNNING FOR RECIRCULATION FOR APPROXIMATELY 3 TO 4 HOURS. IN PREPARATION OF PATIENT CONNECTION, THE RETURN LINE OF THE CIRCUIT WAS CLAMPED OFF AND A LOUD NOISE FROM THE PUMP HEAD THAT SOUNDED LIKE AN UNCOUPLING. THE RETURN LINE WAS UNCLAMPED AND THE PUMP HEAD RESUMED NORMAL OPERATION WITHOUT NOISE. THERE WAS NO PATIENT INVOLVEMENT. UPON FOLLOW-UP WITH THE DIRECTOR OF CLINICAL EDUCATION, IT WAS REPORTED THAT IT LOOKED AS THOUGH THE DAMAGE TO THE PUMP HEAD OCCURRED ON (B)(6) 2025 (ONE DAY PRIOR TO THE REPORTED INCIDENT) WHEN A USER TURNED ON THE SYSTEM AND INCREASED RPMS DESPITE NOT BEING ABLE TO ACHIEVE FLOW. THE PUMP HEAD HAD GROSS AIR CAUSING THE PUMP TO REGISTER RPMS BUT NOT A FLOW AS THE KIT WAS LIKELY DE-PRIMED. ADDITIONALLY, THERE WERE SEVERAL INSTANCES OF THE COMBINATION OF ALARMS SIGNIFYING ¿PUMP THROMBUS¿ WHICH IS UNLIKELY IN CRYSTALLOID SOLUTION BUT WOULD BE EXPLAINED BY THE PUMP HEAD HAVING SOME DAMAGE AND NOT ALLOWING IT TO READILY MEET THE RPM SET POINT. ONCE THE USERS CLAMPED THE CIRCUIT, THE BACK PRESSURE PROVED TOO MUCH TO OVERCOME FOR THE DAMAGED PUMP HEAD AND THEREFORE CAUSED THE NOISE THAT WAS REPORTED. THE COMPLAINT SAMPLE WAS RECEIVED BY XENIOS 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 THEY HAD PREPARED A NOVALUNG CIRCUIT IN ANTICIPATION OF RECEIVING A PATIENT. FOLLOWING PRIMING, MEDICATIONS WERE ADDED TO THE CIRCUIT AND THE PUMP WAS RUNNING FOR RECIRCULATION FOR APPROXIMATELY 3 TO 4 HOURS. IN PREPARATION OF PATIENT CONNECTION, THE RETURN LINE OF THE CIRCUIT WAS CLAMPED OFF AND A LOUD NOISE FROM THE PUMP HEAD THAT SOUNDED LIKE AN UNCOUPLING. THE RETURN LINE WAS UNCLAMPED AND THE PUMP HEAD RESUMED NORMAL OPERATION WITHOUT NOISE. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4, H3 PLANT INVESTIGATION: NON-CONFORMITY WAS NOT OBSERVED DURING MANUFACTURING PROCESS. ONE SIMILAR COMPLAINT HAS BEEN REPORTED FOR THIS BATCH NUMBER. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT EVALUATION. CIRCULAR SCRATCH MARKS WERE VISIBLE AT THE INNER HOUSING OF THE PUMP HEAD, CAUSED BY THE ROTOR RUBBING AGAINST THE INNER HOUSING DURING OPERATION. THE CERAMIC BALL WAS SUNK INTO THE TIP OF THE ROTOR, AND THE TIP OF THE ROTOR WAS DEFORMED. THE PUMP HEAD WAS PROBABLY DAMAGED DURING OPERATION RESULTING IN THE DESCRIBED NOISE. SINCE THE BALL BEARING IS COOLED BY THE LIQUID FLOW IN THE PUMP HEAD, AN ACCUMULATION OF AIR IN THE PUMP HEAD CAN LEAD TO AN INTERRUPTION OF THE COOLING AND DAMAGE OF THE BEARING. THE LOG FILES OF THE CONSOLE INDICATE THAT DAMAGE TO THE PUMP HEAD OCCURRED ON (B)(6) 2025 (ONE DAY PRIOR TO THE REPORTED INCIDENT) WHEN A USER TURNED ON THE SYSTEM AND INCREASED RPMS DESPITE NOT BEING ABLE TO ACHIEVE FLOW. IT WAS LIKELY THAT THE PUMP HEAD HAD GROSS AIR CAUSING THE PUMP TO REGISTER RPMS BUT NOT A FLOW (AS IT WAS LIKELY DE-PRIMED). ADDITIONALLY, THERE WERE SEVERAL INSTANCES OF THE COMBINATION OF ALARMS SIGNIFYING ¿PUMP THROMBUS¿ WHICH IS UNLIKELY IN CRYSTALLOID SOLUTION BUT WOULD BE EXPLAINED BY THE PUMP HEAD HAVING SOME DAMAGE AND NOT ALLOWING IT TO READILY MEET THE RPM SET POINT. ULTIMATELY, THE PUMP HEAD COULD LIKELY BE DE-AIRED AND THE FLOW WAS RESUMED, HOWEVER, ONCE THE CIRCUIT WAS CLAMPED, THE BACK PRESSURE PROVED TOO MUCH TO OVERCOME FOR THE DAMAGED PUMP HEAD, WHICH RESULTED IN THE NOISE THAT WAS REPORTED. THE PUMP HEAD WAS LIKELY DAMAGED DUE TO AIR ACCUMULATION IN THE PUMP HEAD DURING OPERATION. SINCE THE BALL BEARING IS COOLED BY THE LIQUID FLOW IN THE PUMP HEAD, AIR IN THE PUMP HEAD CAN LEAD TO AN INTERRUPTION OF THE COOLING AND DAMAGE OF THE BEARING. THE CONCLUSION IS THAT AN UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONALLY, THE PRODUCT WAS UTILIZED BEYOND THE EXPIRATION DATE.

Description of Event or Problem

A USER FACILITY REPORTED THEY HAD PREPARED A NOVALUNG CIRCUIT IN ANTICIPATION OF RECEIVING A PATIENT. FOLLOWING PRIMING, MEDICATIONS WERE ADDED TO THE CIRCUIT AND THE PUMP WAS RUNNING FOR RECIRCULATION FOR APPROXIMATELY 3 TO 4 HOURS. IN PREPARATION OF PATIENT CONNECTION, THE RETURN LINE OF THE CIRCUIT WAS CLAMPED OFF AND A LOUD NOISE FROM THE PUMP HEAD THAT SOUNDED LIKE AN UNCOUPLING. THE RETURN LINE WAS UNCLAMPED AND THE PUMP HEAD RESUMED NORMAL OPERATION WITHOUT NOISE. THERE WAS NO PATIENT INVOLVEMENT. UPON FOLLOW-UP WITH THE DIRECTOR OF CLINICAL EDUCATION, IT WAS REPORTED THAT IT LOOKED AS THOUGH THE DAMAGE TO THE PUMP HEAD OCCURRED ON (B)(6) 2025 (ONE DAY PRIOR TO THE REPORTED INCIDENT) WHEN A USER TURNED ON THE SYSTEM AND INCREASED RPMS DESPITE NOT BEING ABLE TO ACHIEVE FLOW. THE PUMP HEAD HAD GROSS AIR CAUSING THE PUMP TO REGISTER RPMS BUT NOT A FLOW AS THE KIT WAS LIKELY DE-PRIMED. ADDITIONALLY, THERE WERE SEVERAL INSTANCES OF THE COMBINATION OF ALARMS SIGNIFYING ¿PUMP THROMBUS¿ WHICH IS UNLIKELY IN CRYSTALLOID SOLUTION BUT WOULD BE EXPLAINED BY THE PUMP HEAD HAVING SOME DAMAGE AND NOT ALLOWING IT TO READILY MEET THE RPM SET POINT. ONCE THE USERS CLAMPED THE CIRCUIT, THE BACK PRESSURE PROVED TOO MUCH TO OVERCOME FOR THE DAMAGED PUMP HEAD AND THEREFORE CAUSED THE NOISE THAT WAS REPORTED. THE COMPLAINT SAMPLE WAS RECEIVED BY XENIOS FOR PRODUCT EVALUATION.