Model Number ICF100 |
Device Problems
Display or Visual Feedback Problem (1184); Fluid/Blood Leak (1250)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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As reported, during use of the intra-aortic occlusion catheter, when the vent was turned on the pressure dropped to zero.This resulted in the need to exchange the device.The device is expected for return and evaluation but has not been received at this time.A supplemental report will be submitted upon receiving new information.
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Event Description
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It was reported that during use of an intra-aortic occlusion catheter, the vent was turned and the pressure dropped to zero.The intra-aortic occlusion catheter was removed and a second intra-aortic occlusion catheter was used.This second intra-aortic occlusion catheter also displayed a pressure of zero when the vent was turned on.The surgeon believes there is interaction between the 2 of the lumens causing this to happen.This second occlusion catheter was removed and replaced with a third.This third intra-aortic occlusion catheter worked appropriately and both the patient and the procedure outcome went well.
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Manufacturer Narrative
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Device was returned with visible traces of blood and was examined in the biohazard area of the lab.As received, the ao root pressure connector lumen was kinked.Leakage was observed at the ao root pressure lumen when inflating the ao root infusion lumen.Interlumen leakage was observed between the ao root infusion and ao root pressure lumens within the intraclude hub.Catheter balloon inflated clear and remained inflated for more than 5 min.Without leakage.No other visual damage or other abnormalities were found.Per the product evaluation, the customer report of catheter leakage was confirmed.Per the engineering evaluation, a supplier manufacturing defect was confirmed.A design, ifu, and labeling defect was not confirmed.The trend was reviewed and found to be in control.The root cause will be determined by the vendor.The device history record (dhr) was reviewed and showed that there were no related non-routine ncrs.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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Search Alerts/Recalls
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