ANESTHESIA CIRCUIT KIT FLEX 6
Received Dec 12, 2024
Report 9611500-2024-00563 · MDR key 20910941
Device
Generic name
Anaesthesia Breathing Circuit, Single-use
Manufacturer
Drägerwerk Ag & Co. KgaaModel number
MP02744Lot number
6803.2405.14
Product problems
- Material Disintegration
- Fracture
- Gas/Air Leak
- Material Disintegration
- Fracture
- Gas/Air Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL ON-GOING. THE RESULTS WILL BE PROVIDED WITH A FOLLOW-UP REPORT.
Description of Event or Problem
IT WAS REPORTED THE BREATHING CIRCUIT BROKE AT THE FLEX POINT STRAIGHT THROUGH THE TUBING. NO INJURY REPORTED.
Additional Manufacturer Narrative
THE DESCRIBED ERROR PATTERN COULD BE CONFIRMED BASED ON THE AVAILABLE INFORMATION AND BASED ON THE INVESTIGATION OF RETURNED MATERIAL FROM SIMILAR COMPLAINTS. IT WAS FOUND THAT A CRACK IN THE FLEXIBLE HOSE MOST LIKELY CAUSED BY A MECHANICAL FORCE WAS THE ROOT CAUSE. AN INTERNAL TEST OF THE PULL-OFF FORCES WITH SAMPLE PARTS REVEALED NO DEVIATIONS AND ALL PARTS CONFORMED TO STANDARDS AND SPECIFICATIONS WITH REGARD TO THE PULL-OFF FORCES. FUNCTIONAL TESTS WERE PERFORMED AND IT COULD BE CONFIRMED THAT THE USAGE OF CERTAIN HOSE HOLDERS OR HOSE HOLDER PLATES WITH A FLAT DESIGN CAN CAUSE SUCH CRACKS. IT WAS CONFIRMED THAT HOSE HOLDERS WITH A LARGER CONTACT SURFACE DO NOT PRESS INTO THE INDIVIDUAL FOLDS AS THE FLATTER ONES DO, AVOIDING UNFAVORABLE APPLICATION OF FORCE. LEAKAGES DUE TO CRACKS WILL BE DETECTED DURING THE LEAKAGE TEST OF THE MAIN DEVICE PRIOR TO USE. IN CASE SUCH CRACKS FORM DURING USE, LEAKAGE WILL OCCUR. DEPENDING ON THE SIZE OF THE LEAKAGE AND THE SELECTED VENTILATION PRESSURE, THE VENTILATOR / ANAESTHESIA DEVICE CAN COMPENSATE FOR THIS. IF THE LEAKAGE CANNOT BE COMPENSATED, VENTILATORS ACCORDING TO ISO 80601-2-12 AND ANAESTHESIA DEVICES ACCORDING TO ISO 60601-2-13 WILL GENERATE VISUAL AND AUDIBLE ALARMS ACCORDING TO THE SET ALARM LIMITS. THE DETECTION OF CRACKS IS IMPROVED IF THE LEAKAGE TEST IS ONLY CARRIED OUT AFTER THE EXTENDABLE HOSE HAS BEEN STRETCHED TO THE REQUIRED LENGTH. THIS IS ALSO DESCRIBED IN THE INSTRUCTIONS FOR USE. NEVERTHELESS, THE RISK ASSESSMENT PERFORMED DETERMINED AN INCREASED RISK. IN ORDER TO INFORM ALL CUSTOMERS OF POTENTIALLY AFFECTED BREATHING CIRCUITS ABOUT THE UNACCEPTABLE RISK RESULTING FROM THE SITUATION, A FIELD SAFETY NOTICE WILL BE PUBLISHED IN THE COURSE OF A FIELD SAFETY CORRECTIVE ACTION IN FEBRUARY 2025.
Description of Event or Problem
IT WAS REPORTED THE BREATHING CIRCUIT BROKE AT THE FLEX POINT STRAIGHT THROUGH THE TUBING. NO INJURY REPORTED.