MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA COLLECT SET

Model Number	12120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 13507321
• Report Number: 1722028-2022-00041
• Device Sequence Number: 5324742
• Product Code: GKT
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: BK150251
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: 12120
• Device Catalogue Number: 12120
• Device Lot Number: 2102193130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 09/26/2022; 10/15/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 10/13/2022; 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown