Catalog Number 10226 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
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Event Date 06/03/2022 |
Event Type
Injury
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Event Description
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The customer reported that a patient appeared to have an anaphylactic reaction during a tpe procedure.Per the customer, the patient reported dry throat itching at 17:20.The operator gave the patient 10% calcium gluconate 20ml orally, and reduced the inlet flowrate to 35ml/min.The patient's skin on the neck was itching and showed redness.A rash was noted on the neck and arms at 17:30.The patient felt red sore swollen throat.The operator gave the patient 3mg hexadecadrol by intravenous injection as directed by the physician, and reduced the inlet flowrate to 30ml/min, but nothing improved.The operator had to end the procedure at 17:45.Prior to the procedure, the customer was administered 10% calcium gluconate 20ml.The disposable set is not available for return for evaluation.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
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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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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 a patient appeared to have an anaphylactic reaction during a tpe procedure.Per the customer, the patient reported dry throat itching at 17:20.The operator gave the patient 10% calcium gluconate 20ml orally, and reduced the inlet flowrate to 35ml/min.The patient's skin on the neck was itching and showed redness.A rash was noted on the neck and arms at 17:30.The patient felt red sore swollen throat.The operator gave the patient 3mg hexadecadrol by intravenous injection as directed by the physician, and reduced the inlet flowrate to 30ml/min, but nothing improved.The operator had to end the procedure at 17:45.Prior to the procedure, the customer was administered 10% calcium gluconate 20ml.The disposable set is not available for return for evaluation.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
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Manufacturer Narrative
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This report is being filed to provide additional information in b.6, d.2b, e.1, h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.There were no signals or alarms in the rdf that would indicate issues during the run, specifically the amount of ac delivered.The commanded ac pump speed and the measured ac pump speed were accurate and did not show any discrepancy in pump volume.Based on literature reference, therapeutic apheresis: a physician's handbook, allergic reactions are usually associated with replacement procedures that include blood components but sensitivity to disposable tubing sterilized with ethylene oxide can also be associated with allergic reactions.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 disposable complaint history search was performed for this lot and found a total of 4 occurrences were reported across 2 complaint records from the same customer for similar issues worldwide.See mdr 1722028-2022-00274, mdr 1722028-2022-00275, mdr 1722028-2022-000277, mdr 1722028-2022-00279.Root cause: a root cause assessment was performed for this complaint.Based on customer's statements about the allergic reactions and the literature review, possible causes for the patient reactions include but are not limited to an allergy to replacement solution and/or patient sensitivity to eto.
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Event Description
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The customer reported that a patient appeared to have an anaphylactic reaction during a tpe procedure.Per the customer, the patient reported dry throat itching at 17:20.The operator gave the patient 10% calcium gluconate 20ml orally, and reduced the inlet flowrate to 35ml/min.The patient's skin on the neck was itching and showed redness.A rash was noted on the neck and arms at 17:30.The patient felt red sore swollen throat.The operator gave the patient 3mg hexadecadrol by intravenous injection as directed by the physician, and reduced the inlet flowrate to 30ml/min, but nothing improved.The operator had to end the procedure at 17:45.Prior to the procedure, the customer was administered 10% calcium gluconate 20ml.The disposable set is not available for return for evaluation.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
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Search Alerts/Recalls
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