DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8 FR. 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0684-00-0576-01 |
Device Problems
Restricted Flow rate (1248); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, the console generated catheter restriction and kink alarms after the patient was transferred in from another facility.The same alarm occurred again, but this time the customer could not clear it.The console was put into stand-by for at least 30 minutes, and the customer was then advised to remove the iab.There was no patient harm or adverse event reported.
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, the console generated catheter restriction and kink alarms after the patient was transferred in from another facility.The same alarm occurred again, but this time the customer could not clear it.The console was put into stand-by for at least 30 minutes, and the customer was then advised to remove the iab.There was no patient harm or adverse event reported.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded with traces of blood on the exterior and between the catheter and the returned maquet sheath.The extender tubing was also returned.A catheter tubing/inner lumen kink was observed near the y-fitting at approximately 75.9cm from the iab tip.The inner lumen was found to be broken within a kink inside the membrane at approximately 26.9cm from the iab tip.Lastly, the extracorporeal tubing was returned cut in two pieces at approximately 14.7cm from the rear of the y-fitting.An underwater leak test of the balloon, y-fitting, catheter tubing, extracorporeal tubing and extender tubing was performed and a leak was detected at the inner lumen break location.The iab was placed on the cs300 pump for a complete autofill cycle.The iab did not pump and alarmed.The evaluation was unable to duplicate the reported restriction alarm.However, the kink found on the catheter tubing/inner lumen caused an autofill failure alarm.Additionally, kinks may also cause a restriction alarm.The evaluation confirmed the reported problem.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint (b)(4).
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