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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications are well described in the literature.With any hemodynamic monitoring, values can change quickly and dramatically.Values should correlate with the patient¿s clinical manifestations.If they do not correlate to the clinician¿s satisfaction, it is common clinical practice to abort further attempts to obtain the value(s) in question, and the catheter can be exchanged if desired.It is unknown whether user or procedural factors contributed to the stated event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
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It was reported that during use of a swan-ganz catheter, the rvef right ventricular ejection fraction values were displaying between 20-25%, which was not consistent with the clinical picture.The tapse (tricuspid annular plane systolic excursion) was measured ¿good, indicating good rv ejection¿.They could also see on transesophageal echocardiography (tee) that the ejection fraction (ef) was normal and not as low as the displayed values; however, the exact tee values are unknown.It is unknown if an error message was displayed.The patient was not treated based on the inaccurate values and there was no allegation of patient injury.Patient demographics are unknown and unable to be provided.The lot number was unknown.The device was not available for return.
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