EDWARDS LIFESCIENCES DR CLEARSIGHT FINGER CUFF; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
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Model Number CSCL |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.Lot number was not provided; therefore review of the manufacturing records could not be completed.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Pressure readings should correlate with the patient¿s clinical manifestations.Issues such as poor finger perfusion, improperly applied finger cuff, incorrectly sized finger cuff, improper application of the hrs or failing to zero the hrs sensor may lead to inaccurate hemodynamic measurements.The operators manual instructs the use on these above stated factors that can lead to inaccurate values.It is unknown if user or procedural factors played a role in 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 a part of the monthly review.
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Event Description
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It was reported that during use of a clearsight finger cuff on a male patient the reading was 15mmhg lower than the nibp cuff.The clinician believed the nibp value to be an accurate reflection of the blood pressure.For much of the case it was noted that the clearsight finger cuff and nibp pressure readings were well correlated, but there were two instances where cs was lower.There was no harm to the patient.The cs finger cuff was disposed of following the case.
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Manufacturer Narrative
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Reference capa-20-00141.
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Search Alerts/Recalls
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