Catalog Number 000000000000080300 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Urticaria (2278)
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Event Date 03/29/2015 |
Event Type
No Answer Provided
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Event Description
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The customer reported an allergic reaction in the recipient of platelet products that were collected on a trima system.The patient developed urticaria and hypotension.The customer reported the reaction as unproblematic and stated that the patient is well.The customer reported other similar reactions on different patients.All the platelet products came from different donors.Due to eu personal data protection laws, the patient information is not available from the customer.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 is in process.A follow-up report will be provided.
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Manufacturer Narrative
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Further investigation has determined that the allergic reaction of the recipient occurred with a product that was collected on a device not manufactured by terumo bct.No further evaluation will be performed for this event.
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Search Alerts/Recalls
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