Model Number ULTIMA ACTIVATOR II REUSABLE DRIVE MECH |
Device Problem
Corroded (1131)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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.Device not returned.
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure using ultima activator ii reusable drive mech, the products show clearly recognizable, initial rust formation after they have been processed for the first time.Products were not put into circulation, so products were not used.No patient involvement.
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Manufacturer Narrative
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Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id #: (b)(4).
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure using ultima activator ii reusable drive mech, the products show clearly recognizable, initial rust formation after they have been processed for the first time.Products were not put into circulation, so products were not used.No patient involvement.
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure using ultima activator ii reusable drive mech, the products show clearly recognizable, initial rust formation after they have been processed for the first time.Products were not put into circulation, so products were not used.No patient involvement.
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Manufacturer Narrative
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Trackwise # (b)(4).The device was returned to the factory on 10nov2020.An investigation was conducted on 28dec2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There is evidence of corrosion observed on the device itself.Brown spots can be observed inner edge of the drive mechanism which appears to be rust or corrosion.No other visual defects were observed.Based on the returned condition of the device, the reported failure "corrosion" was confirmed.The dhr shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The lot # 25152118 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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Search Alerts/Recalls
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