Catalog Number C-HSK-3043 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/31/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm umbrella was not released.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the tension spring assembly and on the seal.No other part or component of the device was returned.The seal appeared intact, unfolded and with no signs of cracks nor delamination.The seal was tainted with blood which indicates an attempt for deployment.Based on the returned condition of the device and the evaluation results, the reported failure ¿positioning failure; unable to deploy¿ was not confirmed.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4.3mm umbrella was not released.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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