Catalog Number 70610 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Paralysis (1997); Complaint, Ill-Defined (2331); Reaction (2414); Numbness (2415)
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Event Date 11/05/2015 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is in process.A follow-up report will be provided.
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Event Description
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An article in 'transfusion and apheresis science', november 2015, documented a retrospective analysis of peripheral blood stem cell (pbsc) collections performed (b)(6) 2010 - (b)(6) 2013.Of the collections that were analyzed, there were 63 occurrences of patients suffering from hypocalcemia during the pbsc collections on cobe spectra.The symptoms included perioral paresthesia followed by digital numbness.It is not known at this time if medical intervention was required for the patient reactions.Forty (40) of the 63 patients had been injected with a 5-10ml bolus of 10% calcium gluconate during the procedure as part of the study.Twenty-three (23) of the 63 patients had continuous 10% calcium gluconate infused during the procedure as part of the study.Patient information is not available at this time.This report is being filed for one of the 63 patients.Exact details of each patient reaction are not available at this time.The disposable set is not available for return because it was discarded by the customer.The title of the article is 'prophylactic low dose continuous calcium infusion during peripheral blood stem cell (pbsc) collections to reduce citrate related toxicity.
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Manufacturer Narrative
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Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury based on additional investigational information.The physician in charge, and co-author of the study, confirmed that there was no medical intervention required for the patient reaction.According to the aabb therapeutic apheresis: a physicians handbook, the rate of adverse events during therapeutic apheresis is 4-5%.A specific device history record review could not be performed due to lack of lot information,however, all lots must meet acceptance criteria for release.Root cause: the disposable set was unavailable for return.The study acknowledges that the patient reaction was due to citrate toxicity and understands this is a frequent complication of apheresis procedures.
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Event Description
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Per the customer, no medical intervention was required for this event.
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Search Alerts/Recalls
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