Model Number VASOVIEWHEMPRO VH-3500 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/31/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id# (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 an endoscopic vein harvesting procedure using vasoview hemopro, they switched the co2 from the btt port to distal insufflation on the vh-3500 cannula.They were not able to get co2 to flow through the cannula.They tried connecting and reconnecting as well as cleaning the cannulae but it would not flow.So he switched back to the btt port and finished the case.The hospital did not report any patient effects.
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Manufacturer Narrative
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Corrected section: h-3 - if other provide code -explain.Corrected h-3 from "device not returned" to "device discarded" updated sections: g-4, g-7, h-2, h-3, h-6, h-10.Internal complaint number: tw # (b)(4).
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure using vasoview hemopro, they switched the co2 from the btt port to distal insufflation on the vh-3500 cannula.They were not able to get co2 to flow through the cannula.They tried connecting and reconnecting as well as cleaning the cannulae but it would not flow.So he switched back to the btt port and finished the case.The hospital did not report any patient effects.
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Search Alerts/Recalls
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