VENTSTAR ANESTHESIA

Description of Event or Problem

PLEASE REFER TO THE INITIAL REPORT.

Additional Manufacturer Narrative

A VENTSTAR ANESTHESIA WF 180 TUBING SYSTEM WAS AVAILABLE FOR INVESTIGATION. AS PART OF THE OPTICAL INSPECTION, A DETACHMENT OF THE ELBOW ON THE Y-PIECE COULD NOT BE CONFIRMED. IT WAS NOT POSSIBLE TO CARRY OUT FURTHER TESTS, SUCH AS LEAKAGE, PULL OR CONE TEST, SINCE THE HOSE SYSTEM WAS ALREADY IN USE IN THE HOSPITAL AND TO AVOID POSSIBLE CONTAMINATION OF THE TEST EQUIPMENT. WE HAVE BEEN INFORMED ABOUT ANOTHER REPORTED CASE IN THE PAST 12 MONTHS REGARDING THE REPORTED ERROR. ON THE HOSE SYSTEM PROVIDED FOR THIS CASE, THE ERROR PICTURE COULD ALSO NOT BE COMPREHENDED. SINCE, ACCORDING TO THE INSTRUCTIONS FOR USE, ALL CONNECTIONS MUST BE CHECKED FOR FIRM FIT AND TIGHTNESS PRIOR TO USE, A POTENTIALLY LOOSE CONNECTION IS RELIABLY DETECTED AND CAN BE REMEDIED BY RE-ATTACHING, IF NECESSARY. THE REPORTED LOOSE CONNECTION BETWEEN TUBE AND BLUE CONNECTOR COULD BE COMPREHENDED DURING THE OPTICAL INSPECTION. UPON CLOSER EXAMINATION OF THE LOOSE CONNECTOR, RESIDUAL ADHESIVE WAS VISIBLE. IN PRINCIPLE, THE FAILURE (BROKEN BOND) CAN BE CAUSED BY A TOO SMALL AMOUNT OF ADHESIVE, WHEREBY THE EXACT AMOUNT OF THE ADHESIVE USED CANNOT BE DETERMINED. INCORRECT HANDLING, IN WHICH THE CONNECTORS ARE TOUCHED AND TURNED ON THE BOND AND NOT ON THE CORRUGATION, IS ALSO A CONCEIVABLE ROOT CAUSE OF THE ERROR PATTERN FOUND. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME SYMPTOM, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL ON-GOING. THE RESULTS WILL BE PROVIDED WITHIN A FOLLOW-UP REPORT.

Description of Event or Problem

IT HAS BEEN REPORTED THAT THE VENTSTAR ANESTHESIA SET HAS RELEASED THE BLUE CONNECTORS AND THE ELBOW (OUTGOING FROM THE Y-PIECE). NO PATIENT INJURY REPORTED.