FLOWMETER

Description of Event or Problem

PLEASE REFER TO THE INITIAL-REPORT.

Additional Manufacturer Narrative

THE AFFECTED FLOWMETER WAS PROVIDED FOR INVESTIGATION AND WAS VISUALLY INSPECTED. AN OBVIOUS CRACK AT THE THREAD WAS FOUND. THE PRESSURE DOME OF THE FLOWMETER IS MADE FROM CLEAR POLYCARBONATE TO ALLOW OBSERVATION OF THE INNER FLOW SCALE. THIS TYPE OF PLASTICS IS KNOWN TO BE SUSCEPTIBLE TO ALCOHOLS AND OTHER ORGANIC SUBSTANCES. THE PARTICULAR FLOW METER WAS IN OPERATION FOR APPROX. 10 YEARS AND HAS BEEN REPROCESSED WITH A FORMULATION CONTAINING ALCOHOL. THE IFU CONTAINS A CORRESPONDING WARNING: "RISK OF STRESS CRACKING: DO NOT USE DISINFECTANTS OR CLEANING AGENTS CONTAINING ALCOHOL." FURTHERMORE, THERE ARE RELATED WARNINGS THAT THE PARTS HAVE TO BE INSPECTED FOR MECHANICAL INTEGRITY PRIOR TO EACH USE PARTICULARLY FOR CRACKS IN THE PRESSURE DOME. IT IS ALSO DESCRIBED AS A WARNING THAT ONCE A YEAR THE DEPRESSURIZED PRESSURE DOME HAS TO BE UNSCREWED AND THE THREAD TO BE CHECKED BY SKILLED PERSONNEL FOR IRREGULARITIES AND CRACKS. FINALLY IT CAN BE CONCLUDED THAT REPROCESSING OVER A LONG PERIOD OF TIME WITH A SUBSTANCE CONTAINING ALCOHOL HAS CAUSED THE REPORTED EVENT. TO PREVENT FURTHER INSTANCES OF THIS KIND DISINFECTION AGENTS RECOMMENDED BY DRÄGER HAVE TO BE USED AND ALL OTHER FLOWMETERS AT THE HOSPITAL HAVE TO BE CHECKED FOR CRACKS AND HAVE TO BE EXCHANGED IF NECESSARY.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE PRESSURE DOME OF A FLOW CONTROL TUBE EXPLODED AND THAT THE GLASS FLOW TUBE COVER SHOT AGAINST THE CEILING. NO INJURY REPORTED.