Catalog Number 10220 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Viral Infection (2248)
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Event Date 04/18/2018 |
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 a patient underwent a procedure on spectra optia.It was later found that the patient had contracted creutzfeldt-jakob disease (cjd).Per the customer,they contacted terumo bct to confirm that the patient's blood does not come in contact with the spectra optia device and they reported they do not believe that the optia device was thecause of the patient contracting cjd.The customer declined to provide patient information.The spectra optia exchange 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.Investigation: the customer reported the incident because documentation to the sterility of the set and the closed nature of the set was needed for the customer's internal purposes.The customer is not alleging a deficiency with the device or the disposable.There is no evidence of a device malfunction.Blood does not come into contact with the machine.The customer provided 3 possible lot numbers that were used on 4 different machines, therefore, it is not known which lot number was used on which device.Based on this information, a dhr review was performed for all 3 lots indicated by the customer.The dhr review did not reveal any anomalies that would have contributed to this incident.This record will reflect the investigation for lot number 1802023230.Please refer to mdrs; 1722028-2018-00125, 1722028-2018-00127 and 1722028-2018-00128, which address the 3 remaining optia machines.The spectra optia disposable set was not available for return.The scientific journal discusses the nature of (b)(6) disease.Per internal medical review, it is concluded, the risk of a patient acquiring the tse pathogen that causes (b)(6) infection is minimal when they undergo a therapeutic procedure using the spectra optia therapeutic apheresis system.Root cause: a definitive root cause could not be determined.Possible causes include but are not limited to:- contamination in the transfused plasma- unknown patient exposure route to prions.
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Event Description
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The customer declined to provide patient outcome, if medical intervention was required, the patient stats or any further procedural details.
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Manufacturer Narrative
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This report is being filed to provide additional information.Investigation: per the customer's request, a certificate of compliance for lot # 1802023230 was provided to the customer to ensure sterility of the product.Investigation is in process.A follow-up report will be provided.
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Search Alerts/Recalls
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