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

Catalog Number	10300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Vomiting (2144); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: during follow-up with the customer, it was determined that the pre-procedure ionized calcium and magnesium levels are not being checked.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that during an autologous continuous mononuclear cell (cmnc)collection on the spectra optia device, a patient experienced shivering, vomiting and headache.Per the customer, this patient reaction occurred after one total blood volume (tbv)of the patient was processed.The doctor at the customer site ordered normal saline, iv emset injection, iv pantocid, iv avil and iv paracetamol as a result of the reaction.Per the customer,the patient is reported as "ok".Patient¿s identifier is not available at this time.The spectra optia set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged reactions include but are not limited to the patient's physiology, the patient's disease state, drugs used for mobilization and/or the patient's sensitivity to et0.
Event or Problem Description
After multiple attempts the donor id was not provided by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information and corrected information.Investigation: per customer follow up, the attending physician is suspecting a possible allergic ethylene oxide (eto) reaction.The customer is now using saline rinse option for every procedure and observed no issues during the procedure.The end of run summary information for the procedure was reviewed and it indicated that the device was found to be operating as intended for the procedure based on the data entered by the operator.There was no system or device malfunction identified that may have contributed to the adverse reactions reported.Per therapeutic apheresis handbook: a physician's reference, overall patient reactions may occur in approximately 4.8% of procedures.Of these reactions, most were mild and well tolerated.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The autologous patient was mobilized with grafeel 750 g/day for 5 days.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8120267
• Report Number: 1722028-2018-00319
• Device Sequence Number: 13503374
• Product Code: GKT
• UDI-Device Identifier: 05020583103009
• UDI-Public: 05020583103009
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K172590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2018

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: 05/01/2020
• Device Catalogue Number: 10300
• Device Lot Number: 1805293330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 12/10/2018; 01/09/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 12/20/2018; 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 00034 YR
• Patient Weight: 70