inforMED
MalfunctionBYH

VENTSTAR® COAXIAL WATER TRAP 210

Received Dec 19, 2022 · Event occurred Nov 21, 2022

Report 9611500-2022-00345 · MDR key 16003518

Device

Generic name

Breathing Hose, Disposable

Catalog number

MP00373

Lot number

NA

Product problems

  • Obstruction of Flow
  • Detachment of Device or Device Component
  • Obstruction of Flow
  • Detachment of Device or Device Component

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT AT THE VENSTAR COAX WATERTRAP HOSE THE GLUED JOINT BETWEEN THE PATIENT CONNECTOR HAS ROTATED AND KINKED CAUSING PRESSURE RELATED ISSUES. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

FOR THE INVESTIGATION THE PROVIDED CIRCUIT WAS ANALYSED. THE DESCRIBED PROBLEM COULD BE CONFIRMED. IT WAS FOUND THAT THE ADHESIVE CONNECTION OF THE OUTER HOSE HAD COME LOOSE. THE INNER CIRCUIT WAS STILL CONNECTED WITH THE CONNECTOR SO THAT THE ROTATION OF THE PATIENT CONNECTION RESULTED IN A TWISTING OF THE INNER CIRCUIT. AN ERROR DURING THE BONDING PROCESS IN PRODUCTION WAS IDENTIFIED AS THE ROOT CAUSE. THE ADHESIVE IS APPLIED TO THE CONNECTOR IN A SEMICIRCLE AND DISTRIBUTED BY CIRCULAR MOVEMENTS WHEN THE HOSE IS ATTACHED. INSUFFICIENT BONDING OF THE HOSES OR A BROKEN ADHESIVE CONNECTION CAN RESULT IN REDUCED ADHESION OF THE HOSE TO THE RESPECTIVE CONNECTOR. THIS CAN ADDITIONALLY BE FAVORED BY AN INSUFFICIENT AMOUNT OF ADHESIVE. THE MANUFACTURER HAS INITIATED ADDITIONAL TRAINING FOR EMPLOYEES REGARDING THE BONDING PROCESS AND HAS RAMPED UP VISUAL INSPECTION TO 100% DURING PACKAGING. ACCORDING TO THE INSTRUCTIONS FOR USE THE BREATHING CIRCUIT HAS TO BE CHECKED BEFORE USE. AS A RESULT OF A TWISTED INNER CIRCUIT A BLOCKAGE CAN OCCUR LEADING TO AN INCREASED AIRWAY PRESSURE. THIS IS DETECTED BY THE CONNECTED MAIN DEVICE AND A CORRESPONDING ALARM WILL BE POSTED. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME ROOT CAUSE, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

Additional Manufacturer Narrative

THE INVESTIGATION WAS JUST STARTED. THE RESULT WILL BE FORWARDED IN A FOLLOW-UP REPORT.

Description of Event or Problem

IT WAS REPORTED THAT AT THE VENSTAR COAX WATERTRAP HOSE THE GLUED JOINT BETWEEN THE PATIENT CONNECTOR HAS ROTATED AND KINKED CAUSING PRESSURE RELATED ISSUES. NO INJURY WAS REPORTED.