A reply

Abstract

Thank you for the opportunity to respond to the letter from Drs Liew and Jayamaha. The customers worked in the correct manner and carried out checks and recommendations given in the instructions for use of D-Vapor vaporisers (their reference [1]) and of Professional Standard PS 31 of the Australian and New Zealand College of Anaesthetists, ‘Recommendations on Checking Anaesthesia Delivery Systems’, clauses 4.2.3.2.3 and 4.2.3.2.4 (their reference [2]). They observed a fresh gas leak caused by inappropriate handling of a D-Vapor and found the reason for that to be a broken part of the bolt of Selectatec-compatible plug-in adapter S-2000. The damaged vaporiser had been replaced and the broken part was removed from back bar. With an alternative D-Vapor, all tests and checks in combination with the cited anaesthesia machine were passed. During the investigation, the customer found that excessive force during previous handling was the most likely cause of breaking the locking bolt of the plug-in adapter. Excessive force during handling would constitute improper handling of the device. Our instructions for use state that ‘D-Vapor has to be handled with care’. The vaporiser discussed must be repaired by trained personnel who have had product-specific Draeger training. Training of the operating room staff using the anaesthesia system shall be conducted again. We are grateful for being made aware of the issue and the advice of the author to check and/or to improve the locking mechanism with respect to the bolt material used. The locking mechanism has been present on anaesthesia machines from both GE/Datex Ohmeda and Draeger for decades. The parts of the locking mechanism are specified as metal parts and were verified/validated by wear and tear tests as well as lifetime endurance tests in conjunction with the plug-in connector, better known as ‘back bar’ or ‘mounting bar’. Our worldwide Quality Surveillance System does not reveal any accumulated reports of the adapter or the bolt in particular. For these reasons, we would not anticipate a need to change the design of the adaptor or the bolt in particular. In conclusion, we recommend appropriate handling of medical devices and want to reassure all customers of Draeger-Vapor vaporisers equipped with a Selectatec-compatible plug-in adapter S-2000, that the design is field-established, certified by TÜV SÜD (a testing and certification body) and received a CE certificate of compatibility in 2006.