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MalfunctionQJZ

XLUNG KIT 230

Received May 28, 2025 · Event occurred Mar 22, 2025

Report 3012172416-2025-00051 · MDR key 22094680

Device

Generic name

Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure

Manufacturer

Xenios Ag

Catalog number

32000014

Lot number

ESXM0409

Product problems

  • Defective Component
  • Material Split, Cut or Torn
  • Defective Component
  • Material Split, Cut or Torn

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 DURING CIRCULATION OF A PRIMED KIT OVERNIGHT, THE PRIMING BAG RIPPED FROM THE INFUSION POLE AND FELL TO THE GROUND. FOLLOWING THIS, THE PUMP HEAD ENTRAINED AIR AND MADE CRACKLING SOUNDS WHEN THE ISSUE WAS DISCOVERED THE FOLLOWING MORNING. THERE WAS NO PATIENT INVOLVEMENT. UPON FOLLOW-UP, IT WAS REPORTED THE TEAR IN THE PRIMING BAG WAS MORE THAN LIKELY A MANUFACTURING DEFECT. THERE WAS VISIBLE DAMAGE ON THE WHITE COVER OF THE PUMP DRIVE; HOWEVER, THE PUMP DRIVE WAS STILL FUNCTIONAL. NO PRODUCT IS AVAILABLE FOR EVALUATION.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D3, D4, G1, H6 PLANT INVESTIGATION: NONCONFORMITY DURING THE MANUFACTURING PROCESS DID NOT FOLLOW THE SAME FAILURE PATTERN. COMPLAINTS FOR THIS BATCH NUMBER DID NOT FOLLOW THE SAME FAILURE PATTERN. THE MACHINE FILES OF CONSOLE XEN0672 WERE PROVIDED. THE CONSOLE WAS STARTED ON MARCH 20, 2025. THE DATA SUGGESTS THAT THE DISPOSABLE CIRCUIT HAD ALREADY BEEN FILLED WHEN THE CONSOLE WAS STARTED. THE DATA INDICATES THAT DUE TO THE FALLING PRIMING BAG, THE TUBING AND THE PUMP HEAD RAN DRY WHICH RESULTED IN A DECREASE OF THE FLOW AND SUBSEQUENTLY NO FLOW. NO FLOW COULD BE MEASURED BECAUSE THERE WAS NO FLUID IN THE TUBING (ALARM #211). THE PUMP HEAD LIKELY WAS DAMAGED WHILE RUNNING DRY (ALARMS #103 AND #225).

Description of Event or Problem

A USER FACILITY REPORTED THAT DURING CIRCULATION OF A PRIMED KIT OVERNIGHT, THE PRIMING BAG RIPPED FROM THE INFUSION POLE AND FELL TO THE GROUND. FOLLOWING THIS, THE PUMP HEAD ENTRAINED AIR AND MADE CRACKLING SOUNDS WHEN THE ISSUE WAS DISCOVERED THE FOLLOWING MORNING. THERE WAS NO PATIENT INVOLVEMENT. UPON FOLLOW-UP, IT WAS REPORTED THE TEAR IN THE PRIMING BAG WAS MORE THAN LIKELY A MANUFACTURING DEFECT. THERE WAS VISIBLE DAMAGE ON THE WHITE COVER OF THE PUMP DRIVE; HOWEVER, THE PUMP DRIVE WAS STILL FUNCTIONAL. NO PRODUCT IS AVAILABLE FOR EVALUATION.