Catalog Number 000000000000010220 |
Device Problem
Temperature Problem (3022)
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Patient Problems
Tachycardia (2095); Alteration In Body Temperature (2682)
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Event Date 05/16/2015 |
Event Type
Injury
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Event Description
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The customer reported that during rinseback after a therapeutic plasma exchange (tpe)procedure, the patient experienced a raised temperature and raised heart rate.The rapidresponse team was called and the patient was given clonadine 0.3mgs, tylenol 650 mgs andlasix 100mg in response to the event.The patient is in stable condition.The disposable set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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Investigation: per the customer, fluids hanging were anti-coagulant acda and normal saline.Replacement fluid used was 5% albumin.Investigation is in process.A follow-up report will be provided.
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Manufacturer Narrative
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(b)(4).Investigation: the disposable set was unavailable for return and investigation.The run data file (rdf) was analyzed for this event.Based on an evaluation by the physician, the symptoms were due to the patient's physiology.A service call was placed for the machine.Upon inspection, the machine alerted that there was a dirty fluid detector which was then cleaned.There was also an alarm for a malfunctioning door latch.The machine performed as designed and these alarms would not have contributed to the patient¿s reaction which occurred after the procedure.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The spectra optia system has many safety features.However, a patient reaction can occur rapidly.Therefore, it is imperative that the operator monitor the patient and the system throughout the procedure.The physician suspects the patient had an allergic reaction or an episode of pulmonary edema.Root cause: a definitive root cause for the patient reaction could not be determined.Based on the rdf analysis and the machine service call, the system performed as designed.A possible cause is but not limited to the patients pre-existing condition.
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Manufacturer Narrative
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This record was identified during a retrospective review of mdr's, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury in the mdr form.This supplement is being filed to modify information per fda request.
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Search Alerts/Recalls
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