Catalog Number 10220 |
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)
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Event Date 10/28/2023 |
Event Type
Injury
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Event Description
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The customer reported a patient had an allergic reaction of rashes and itching on the face, neck, hands during a therapeutic plasma exchange (tpe) procedure.Medical intervention for the reaction was injection of hydrocortisone, 2cc of avil and dexamethasone.The patient recovered after antihistamines and steroid injections.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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Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.Investigation is in process, a follow-up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information in 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.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a root cause assessment was performed for the allergic reactions.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: hypersensitivity to the ethylene oxide used to sterilize the disposable set.Hypersensitivity to the components inside the disposable set.Hypersensitivity to the replacement fluids, such as fresh frozen plasma (ffp); patient's underlying disease state or sensitivity to the apheresis procedure.
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Event Description
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The customer reported a patient had an allergic reaction of rashes and itching on the face, neck, hands during a therapeutic plasma exchange (tpe) procedure.Medical intervention for the reaction was injection of hydrocortisone, 2cc of avil and dexamethasone.The patient recovered after antihistamines and steroid injections.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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