XLUNG KIT 230
Received Mar 20, 2025 · Event occurred Mar 3, 2025
Report 3012172416-2025-00029 · MDR key 21651088
Device
Generic name
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
Manufacturer
Xenios AgCatalog number
32000014
Lot number
FSXE2015
Product problems
- Crack
- Leak/Splash
- Material Integrity Problem
- Crack
- Leak/Splash
- Material Integrity Problem
Patient
NA · Unknown
- No Consequences Or Impact To Patient
- Insufficient Information
- No Consequences Or Impact To Patient
- Insufficient Information
Narrative
Description of Event or Problem
A USER FACILITY REPORTED THAT A VENTING PORT OF AN OXYGENATOR WAS FOUND DAMAGED. A PHYSICIAN FOUND THE FAILURE THAT LED TO LEAKAGE DURING PRIMING. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. UPON FOLLOW-UP IT WAS REPORTED THE VENTING PORT AT THE TOP OF THE OXYGENATOR WAS BROKEN OFF. NO FURTHER DAMAGE TO THE KIT OR PACKAGING WAS NOTED. THE COMPLAINT SAMPLE WAS RECEIVED ON 19/MAR/2025 FOR PRODUCT INVESTIGATION.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D4, H3. PLANT INVESTIGATION: NONCONFORMITY WAS NOT OBSERVED DURING THE MANUFACTURING PROCESS. NO OTHER COMPLAINTS HAVE BEEN SUBMITTED FOR THIS BATCH NUMBER. THE SAMPLE WAS RECEIVED AND DAMAGE OF THE OUTER PACKAGING WAS NOTICED. IT IS ASSUMED THAT AT LEAST SOME OF THIS DAMAGE OCCURRED DURING RETURN SHIPMENT. A SMALL TEAR WAS FOUND IN THE HOLDING TRAY FOR THE OXYGENATOR. NO FURTHER DAMAGE OF THE INNER PACKAGING OR TRAY WAS FOUND. THE VENOUS VENTING PORT AT THE TOP OF THE OXYGENATOR WAS FOUND BROKEN AT THE 90 DEGREE ANGLE OF THE PORT. NO FURTHER DAMAGE WAS FOUND AT THE OXYGENATOR OR THE KIT. THE VENTING PORT MOST LIKELY BROKE DUE TO VIBRATIONS DURING TRANSPORT. DUE TO THE 90 DEGREE ANGLE OF THE VENTING PORT ON THE LID OF THE OXYGENATOR, THERE IS AN INCREASED NOTCH EFFECT ON THE INNER EDGE. AS A RESULT, THERE IS A RISK THAT THE PORT WILL BREAK AT THIS POINT IN THE EVENT OF IMPACTS DURING TRANSPORT. SIMULATIONS SHOW THAT THE PORT BREAKS AT A PRESSURE LOAD OF 39 N. A REVIEW FOR SIMILAR COMPLAINTS AND COMPLAINTS OF THE GIVEN BATCH REVEALED NO NEGATIVE TREND IN THE OCCURRENCE RATE OF THE ERROR PATTERN. COMPLAINTS OF THIS TYPE WILL CONTINUE TO BE MONITORED.
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 A VENTING PORT OF AN OXYGENATOR WAS FOUND DAMAGED. A PHYSICIAN FOUND THE FAILURE THAT LED TO LEAKAGE DURING PRIMING. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT. UPON FOLLOW-UP IT WAS REPORTED THE VENTING PORT AT THE TOP OF THE OXYGENATOR WAS BROKEN OFF. NO FURTHER DAMAGE TO THE KIT OR PACKAGING WAS NOTED. THE COMPLAINT SAMPLE WAS RECEIVED ON 19/MAR/2025 FOR PRODUCT INVESTIGATION.