Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is ongoing.Further information has been requested but has not yet been received.A follow-up emdr will be submitted when additional information becomes available.
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Event Description
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The event occurred in united kingdom.It was reported that a suspected ruptured fiber in the oxygenator was noticed.The hls set was exchanged during patient treatment.No harm to any person has been reported.Complaint id: (b)(4).
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Manufacturer Narrative
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It was reported that a suspected ruptured fiber in the oxygenator was noticed.The hls set was exchanged during patient treatment.The affected product was investigated in the getinge laboratory on 2022-09-02.During visual inspection no damage or abnormalities could be detected.During the performance of the leak test blood side, a leakage occurred from the emergency gas outlet of the product.Therefor the reported failure could be confirmed.The exact root cause could not be determined.The most possible root cause could be determined as the following: insufficient pur (polyurethane) potting of the mat package.Fiber detachment in the pur potting.Fiber damage.The production records of the affected be-(b)(4) #shls module advanced adult with lot#3000210013 were reviewed on 2022-09-06.According to the final test results, the hls module with lot#3000210013 and udi#(b)(4).Passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results the reported failure "leakage at the gas outlet connector" could be confirmed.Maquet cardiopulmonary initiated a non-conformance process in regards to the detected findings.All further actions and investigations will be performed within this process.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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