EDWARDS LIFESCIENCES, PR SWAN-GANZ OXIMETRY TD CATHETER; CATHETER, OXIMETER, FIBEROPTIC
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Model Number SWAN GANZ UNKNOWN |
Device Problems
Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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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 10/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor can a root cause or any 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.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, and should correlate with the patient¿s clinical manifestations.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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Event Description
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It was reported that during use of the swan-ganz catheters, the customer felt they¿ve been receiving ¿inconsistent ci and svo2 values.¿ per hospital protocol, they run a mixed venous oxygen saturation (svo2) on patients with a cardiac index (ci) less than 2.0, and from that svo2 value, they were making assumptions for what the ci ¿should be." the customer uses philips (non-edwards brand) bedside monitors for the calculation of ci not edwards.No error messages are believed to have been noted.The customer reported this to have occurred in 10 instances; however, have not provided a response to follow-up attempts for the affected model and lot number(s), specific dates of occurrence, displayed values vs.Expected values, any observed error messages and troubleshooting methods, and patient demographics for each of the reported 10 catheters.Additionally, the customer has not provided a response to follow-up attempts at determining the availability of any/all of the 10 suspect devices for return.There was no allegation of any patient injury or inappropriate treatment resulting from the ci values.Of note, the edwards reps performed a follow-up walk through with the customer in each of the cardiac units to answer questions or concerns from staff, for which they didn¿t encounter any.The representatives for philips brand products had also been on site prior to the edwards representatives visit, and were reported to have confirmed there were no issues on their end.
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Manufacturer Narrative
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Corresponding mdr numbers: 2015691-2018-04437, 2015691-2018-04438, 2015691-2018-04439, 2015691-2018-04440, 2015691-2018-04441, 2015691-2018-04442, 2015691-2018-04443, 2015691-2018-044454, 2015691-2018-04445.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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