EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBEROPTIC
|
Back to Search Results |
|
Model Number 777F8 |
Device Problems
Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/30/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
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 and should correlate with the patient¿s clinical manifestations.If they do not correlate to the clinician¿s satisfaction, it is common clinical practice to the abort the attempt to obtain the desired value(s) 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.
|
|
Event Description
|
Per the edwards sales representative, he has been rolling out the hemosphere monitors at the hospital and on two occasions, during use of a model 777f8 swan-ganz catheter, the svo2 did not line up to the mixed venous samples drawn from the patient.In this instance, the svo2 measured 49 on the monitor and the patient sample measured 55.The monitor had been calibrated the night before, so it is unknown if the hemoglobin (hgb) value was updated.The patient was not treated based on the initial readings.It was noted that at the time of the reporting, the suspect catheter was in use and functioning appropriately so the customer will not be returning it.It is not known how the issue was resolved or if the issue was initially due to catheter positioning.There was no patient injury and patient demographics are unknown.The lot number is unknown.
|
|
Manufacturer Narrative
|
Reference capa-20-00141.
|
|
Search Alerts/Recalls
|
|
|