Catalog Number C-HS-3045 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/18/2018 |
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 was no nonconformance recorded in the lot history.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 did not deploy properly in the patient's aorta and came out when the customer pulled out the delivery device.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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Corrected section: event site city and event site postal code; lot # and expiration date; manufacture date.(b)(6).Corrected lot # from "25135578" to "25136334".Corrected expiration date from "11/16/2018" to "01/08/2019".Corrected mfr date from "11/16/2017" to "01/08/2018".(b)(4).
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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 did not deploy properly in the patient's aorta and came out when the customer pulled out the delivery device.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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