Customer recently had a circuit on a patient for about 3 weeks, when the oxygenator started dripping blood slowly.Not from the exhaust port, but from the bottom plastic.Clinicians watched it for a couple days, because they were not sure it was actually leaking.It was very slow and would crust up at the bottom.Clinicians changed the circuit and inside the area on the cardiohelp machine, where you seat the pump, it was all crusted with blood.They could not see it until they removed the pump/oxygenator.After customer closely inspected the pump and oxygenator, it appeared there was a tiny crack in the pump housing.Complaint #(b)(4).
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It was reported that customer recently had a circuit on a patient for about 3 weeks, when the oxygenator started dripping blood slowly.Not from the exhaust port, but from the bottom plastic.Clinicians watched it for a couple days, because they were not sure it was actually leaking.It was very slow and would crust up at the bottom.Clinicians changed the circuit and inside the area on the cardiohelp machine, where you seat the pump, it was all crusted with blood.They could not see it until they removed the pump/oxygenator.After customer closely inspected the pump and oxygenator, it appeared there was a tiny crack in the pump housing.The affected product was not available for further investigation.Therefore no technical investigation could be performed.However following events can contribute to cracks on the pump housing, which is assessed in our risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # 1468452, v26): -mechanical damage to the connector due to high tensile force and mechanical hit the most probable root cause for the reported failure "leakage pump housing" could be the crack which was detected by the clinicians.The production records of the affected hls module were reviewed on 2021-10-20.Following tests are performed according to the bop as a 100 % inspection: gluing luer lock, pressure test blood side, tightness test gas side, final product test.According to the final test results, all oxygenators passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on these investigation results and the given information the reported failure "leakage pump housing" could be confirmed.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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