It was reported that the customer noticed air in the circuit and was unable to remove the air out of the circuit.They decided to exchange the affected hls set with another hls set.They also exchanged the second hls set due to air in the circuit.With the third hls set they have no problems.No harm to any person has been reported.The affected products were technical investigated in the getinge laboratory on 2022-09-16.During priming and a subsequent flow test of both modules, no more air could be detected.Subsequently, a leak test (gas side) was carried out on both complaint samples, which were both passed as tight.Based on the investigation results the reported failure was not reproducible for both samples.However, the failure mode "air remains in system" can be linked to the following most possible root causes according to our risk management file (dms#(b)(4)): hls is not primed.Clamp is not used.Hls is positioned above patient.Pump is started without content.De-airing membrane closed during priming.The production records of the affected two beq-015703112 #shls module advanced adult with packaging lot#3000208256 were reviewed on 2022-09-22.According to the final test results, the hls modules with lot#3000208256 and udi#(b)(4) passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results the reported failure "air remains in system" could not be confirmed.In order to avoid re-occurrence of the reported failure, the sales and service unit (ssu) will inform the customer to follow the chapter in the instructions for use hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0 g-660 v04 us: follow the chapter 6.2 priming the system during the priming process.6.4 starting perfusion: ensure that the tube system has been completely de-aired before starting the perfusion.Ensure that all connections and luer lock openings are secured or closed before you start extracorporeal circulation.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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