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Model Number BE-HMOD 30000 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/18/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device has been requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.
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Event Description
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According to the customer: pediatric patient with diagnosis of respiratory failure.Vv ecmo was performed using avalon double lumen catheter and quadrox id pediatric with tubing set ((b)(4)).After initial of vv ecmo, patient blood gas, pre/post membrane blood gas was checked and revealed the post membrane po2 108 mmhg (with fio2 1.0, while pco2 was in normal range.Perfusionist double check the connection of gas line , changing the gas blender , check the leakage of gas pipe line.Alls are secure and no abnormal was detect, then the 2nd post membrane blood gas was repeated and still revealed slightly low at 114.7 mmhg.Customer suspect sign of membrane oxygenator failure.The cardiac surgeon and perfusionist decided to change the circuit with new quadrox id and repeat blood gas after circuit change revealed post membrane oxy po2 at 633 mmhg.With fio2 1.0.No abnormal of patient condition were noted (b)(4).
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Manufacturer Narrative
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The returned product was investigated at the laboratory of the manufacturer.During visual inspection clots were noted at the blood inlet and blood outlet side.To ensure performance of the products prior to shipment, checks, controls, and performance tests are carried out during the manufacture of the products.These tests can be reviewed as part of a dhr review.There were no references found, which are indicating a nonconformance of the product in question.Additionally a review of the weekly performance monitoring according to si-c-09 has been reviewed, the performance tests passed the acceptance criteria.Based on the results obtained during investigation at this time the cause of the reported incident was determined to not be attributed to a device related malfunction.Thus the reported failure could not be confirmed.
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Event Description
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(b)(4).
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Search Alerts/Recalls
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