Model Number VASOVIEW 7 XB BISECTOR (US) |
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 01/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id #289165 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 7 xb bisector.Customer experienced high co2 pressure alarm.After troubleshooting customer has indicated the issue is with the btt.They have exchanged tower, co2 tubing and alarm continues.When they remove the trocar from the leg and reconnect it, the alarm continues to occur.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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H3 correction: the device was discarded.Internal complaint number: (b)(4).
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure using vasoview 7 xb bisector.Customer experienced high co2 pressure alarm.After troubleshooting customer has indicated the issue is with the btt.They have exchanged tower, co2 tubing and alarm continues.When they remove the trocar from the leg and reconnect it, the alarm continues to occur.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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