Catalog Number C-HSK-3038 |
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 07/06/2018 |
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 3.8mm deployed incorrectly.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).Signs of clinical use and evidence of blood were observed.The delivery device was returned outside the loading device.The slide lock on the deliver device was disengaged and the plunger was fully depressed.There was blood on and inside the delivery tube and the delivery device indicating that an attempt was made to deploy the seal.The seal and the tension spring assembly were inside the delivery device with the seal hanging outside the tube and the tension spring assembly inside the tube indicating a successful deployment of the seal.The seal was covered in blood, was circular and intact without any delamination or cracks.The delivery tube could not be measured because of the presence of blood inside it.Based on the return condition of the device and the evaluation results the reported complaint was not confirmed for the reported failure mode "positioning failure".
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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 3.8mm deployed incorrectly.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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