Model Number VASOVIEW HEMOPRO 2 |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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Trackwise id # (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 balloon of the bbt port was broken and could not be expanded.The procedure was continued as it was, but since the pneumoperitoneum pressure could not be secured, the continuation of the procedure (erah) was abandoned and the radial artery was collected openly.There was no effect on the patient.
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Manufacturer Narrative
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Trackwise # (b)(4).Updated sections: g4, g7, h2, h6, h10.The lot #25150926 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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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 balloon of the bbt port was broken and could not be expanded.The procedure was continued as it was, but since the pneumoperitoneum pressure could not be secured, the continuation of the procedure (erah) was abandoned and the radial artery was collected openly.There was no effect on the patient.
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Search Alerts/Recalls
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