The product is expected to be returned for analysis but has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.No actions will be taken at this time.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Complaint histories for all reported events are reviewed against trending control limits, and any excursions above the control limits are assessed and documented as part of this monthly review.
|
It was reported that a 777f8 swan-ganz catheter was giving inaccurate readings.The patient was transferred to the icu from the or with the swan-ganz catheter in place.The line placement was confirmed with xray and measurement.It was giving low cardiac output and cardiac index readings with normal sv02 readings.The cardiac output and cardiac index readings were significantly lower than readings obtained in or.The rest of the hemodynamic profile did not match the cardiac output and cardiac index data.The catheter was recalibrated at bedside with mixed venous sample, re-zeroed, and repositioned by the pa without resolution.A new swan-ganz catheter was floated at the bedside by the pa with resolution of the issue.There was no patient injury.
|