Model Number HMOD 70000-USA |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported during an ecmo perfusion observed h2o leaking from the heather cooler unit out of the gas outlet port of oxygenator.Oxygenator was clamped out and exchanged with another oxygenator.No adverse patient complication was observed.With reference to sus voluntary event report mw5101358.The affected product was not yet returned to the manufacturer for technical investigation.The investigation of the manufacturer is still pending.
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Event Description
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It was reported during an ecmo perfusion observed h2o leaking from the heather cooler unit out of the gas outlet port of oxygenator.Oxygenator was clamped out and exchanged with another oxygenator.No adverse patient complication was observed.With reference to sus voluntary event report mw5101358.Complaint id: (b)(4).
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Manufacturer Narrative
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It was reported during an ecmo perfusion observed h2o leaking from the heather cooler unit out of the gas outlet port of oxygenator.Oxygenator was clamped out and exchanged with another oxygenator.No adverse patient complication was observed.With reference to sus voluntary event report mw5101358.The affected product was investigated at the laboratory of the manufacturer.During a tightness test of the oxygenators water side a leakage at the hansen connector right at the oxygenators housing (on the left side under the blood outlet) was detected.The bridge, which stabilized this connector, was found broken.The leakage was caused by a crack.The hansen connector is during use connected to the heat exchanger unit which is operating with water.The reported failure "h2o leaking out of the gas port" was caused by the leakage found at the hansen connector which allows small water drops flowing down at the housing and collecting at the gas outlet / bottom of the oxygenator.The patients blood circuit was not exposed to water due to the detected leakage.Thus the reported failure could be confirmed.Based on the investigation results the detected leakage at the hansen connector was most probable caused by excessive physical force during handling of the product.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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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Event Description
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Complaint id: (b)(4).
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Search Alerts/Recalls
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