Catalog Number 10220 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Bradycardia (1751); Cardiac Arrest (1762); Loss of consciousness (2418); Decreased Respiratory Rate (2485)
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Event Date 02/16/2014 |
Event Type
Injury
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Event Description
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The customer reported that a patient went into cardiac arrest during a therapeutic plasmaexchange (tpe) procedure.Ninety minutes into the procedure, the patient's respiratory and heartrate declined and he became unresponsive.A medical code was called.The patient remained inicu after the incident.Per the customer, the patient was then stable enough to be transferred to another hospital.Customer declined to provide patient identifier.The disposable set is unavailable for return because the customer discarded it.This report is being filed due to a code being called for the patient.
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Manufacturer Narrative
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Investigation: a service call was placed and the technician performed an autotest and saline procedure with no unexpected alarms.Investigation evaluation and corrective actions are in-process.A follow-up report will be provided.
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Manufacturer Narrative
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Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.The run data file (rdf) was analyzed for this event.Root cause: the disposable set was unavailable for specific root cause analysis.A definitive root cause could not be determined.Signals in the rdf showed the machine operated as intended.Possible causes for the patient reaction include but are not limited to the patient's disease state and/or reaction to fresh frozen plasma.The spectra optia apheresis system essentials guide provides the following warning for solutions and medicinal fluids: "when using biologically-derived replacement fluids, closely monitor the patient for reactions.".
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Event Description
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The customer stated they were not able to release the patient identifier, medical history or the reason for the tpe procedure.
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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 on 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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