Catalog Number 70600 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Fever (1858); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Chills (2191); Reaction (2414); Shaking/Tremors (2515)
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Event Date 06/06/2015 |
Event Type
Injury
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Manufacturer Narrative
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Investigation: the inlet ac ratio for the procedure was 1:12.Investigation is in process.A follow-up report will be provided.
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Event Description
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The customer reported that 15 minutes into a stem cell collection procedure, the patient experienced a reaction.They had chills with rigors, vomiting, hypotension and fever.The customer used heparin as an anticoagulant after the reaction.It is unknown if medical intervention was required for this event.Patient information is unavailable at this time.Patient outcome is unavailable at this time.Terumo bct is awaiting return of the disposable set for evaluation.
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Manufacturer Narrative
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Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The disposable kit was requested but was not available for further analysis.The customer stated that they performed an internal investigation but could not determine the cause of the reaction.The customer has begun to use cobe spectra again without any adverse events.The on-site physician stated that the adverse event was not caused by the equipment or disposable kit.Per the cobe spectra essentials guide, the cobe spectra system has many safety features.A patient reaction can occur rapidly, however.It is imperative that the operator continuously monitor the cobe spectra system and the donor and/or patient.Root cause: although a definitive cause for the adverse reaction could not be determined, the customer¿s internal review concluded that the equipment and disposable kit were not defective.It is possible that the patients¿ physiology caused the reaction.
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Event Description
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The patient's condition did not deteriorate further after the procedure and no further care for the symptoms was required.The customer declined to provide patient information.
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Search Alerts/Recalls
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