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Model Number 82520 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Itching Sensation (1943); Rash (2033); Tinnitus (2103); Respiratory Insufficiency (4462)
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Event Date 05/17/2023 |
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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The customer reported that 25 minutes after starting apheresis the donor began to present redness on the face, arms, shoulders, and neck, and reported that the donor was also itching and had a sensation of heat along with mild shortness of breath and tinnitus.Loratadine was administered orally and the donor vomited and then 100mg of hydrocortisone was administered intravenously and a 10mg dose of loratadine was repeated orally.The customer reported that the symptoms began to subside after 5 minutes.The customer reported after 24 hours the donor reported a generalized slightly itchy rash and it was indicated that 10 mg of cetirizine was taken.The patient is in stable condition.Patient id and weight are not available at this time.The collection set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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This report is being filed to provide additional information in a.4, b.5, h.6 and h.10.Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.According to aabb technical manual 20th edition, adverse reactions can occur at the time of donation or after the donor has left the blood center.In a comprehensive donor hemovigilance program reported by the american red cross, adverse reactions were reported for wb collections (349 in 10,000), plateletpheresis (578 in 10,000), and double rbc unit collections (538 in 10,000), the vast majority of which were minor presyncopal reactions and small hematomas.Serious adverse reactions were slightly more common for wb collections (7.4 in 10,000) compared with plateletpheresis (5.2 in 10,000) and double rbc unit collections (3.3 in 10,000).Reactions that needed medical care after the donor left the donation site occurred in roughly 3 in 10,000 donations.Root cause: a root cause assessment was performed for this complaint.A definitive root cause for the donor's reaction could not be determined.Possible causes for the alleged reaction include but are not limited to donor's physiology and/or donor's sensitivity to the procedure.
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Event Description
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The customer reported that 25 minutes after starting apheresis the donor began to present redness on the face, arms, shoulders, and neck, and reported that the donor was also itching and had a sensation of heat along with mild shortness of breath and tinnitus.Loratadine was administered orally and the donor vomited and then 100mg of hydrocortisone was administered intravenously and a 10mg dose of loratadine was repeated orally.The customer reported that the symptoms began to subside after 5 minutes.The customer reported after 24 hours the donor reported a generalized slightly itchy rash and it was indicated that 10 mg of cetirizine was taken.The patient is in stable condition.The customer declined to provide the customer identifier.The collection set is not available for return because it was discarded by the customer.
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Search Alerts/Recalls
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