Model Number 12120 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 01/18/2022 |
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 the patient had a reaction to anticoagulant with hypocalcemia and tetany.Patient information and outcome are unknown 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 h.6 and h.10.Investigation: the customer reported a patient reaction to anticoagulant with hypocalcemia and tetany.Patient information and extent of medical intervention remain unknown because the customer declined to provide these details stating there was no adverse event related to the incident.A dlog analysis could not be performed since the run files were not available on our server and the customer declined the request for collection.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 therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as parasethesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Investigation is in process.A follow-up report will be provided.
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Event Description
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The customer reported the patient had a reaction to anticoagulant with hypocalcemia and tetany.Patient information and outcome are unknown 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 h.6 and h.10.Investigation: the customer reported a patient reaction to anticoagulant with hypocalcemia and tetany.Patient information and extent of medical intervention remain unknown because the customer declined to provide these details stating there was no adverse event related to the incident.A dlog analysis could not be performed since the run files were not available on our server and the customer declined the request for collection.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 therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as parasethesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Root cause: 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: * ac management during the procedure * patient disease state * patient sensitivity to anticoagulant.
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Event Description
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The customer reported the patient had a reaction to anticoagulant with hypocalcemia and tetany.The customer declined to provide patient information.Per the customer, they were able to continue the procedure.The extent of medical intervention remains unknown because the customer declined to provide these details stating there was no adverse event related to the incident.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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