EDWARDS LIFESCIENCES, PR SWAN-GANZ BIPOLAR PACING CATHETER (FOR FEMORAL INSERTION); CATHETER, FLOW DIRECTED
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Model Number D97130F5 |
Device Problem
Pacing Problem (1439)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/10/2021 |
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.Lot number was not provided; therefore review of the manufacturing records could not be completed.Although no fault was found, an investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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 when the staff tried to pace the patient, it was unable to capture.They changed the temporary pacer box and it was able to work.There was no patient injury.The patient demographics were received.
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Search Alerts/Recalls
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