Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0 |
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 07/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Further details about the product and event were requested but still pending.A follow-up emdr will be submitted when additional information becomes available.
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Event Description
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The customer reported that an hls 7.0 had cracked.No harm to patient was reported and the product was exchanged during treatment.Complaint id: (b)(4).
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Manufacturer Narrative
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It was reported that blood was leaking at the pump housing due to a crack.The device was being used for treatment.The hls set was disposed by the customer thus no technician investigation could be performed.A picture provided by the customer shows a leakage at the pump housing.A review of the trend data for similar complaints was performed and no similar complaints were found.According to the hls set risk assessment the most probable root cause was determined as a mechanical damage caused by external influences.The production records of the affected hls module were reviewed on 2021-10-27.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 the investigation results no product related malfunction could be confirmed.The occurrence rate was calculated for the reported failure 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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Event Description
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Complaint id: (b)(4).
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Search Alerts/Recalls
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