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

Catalog Number 10300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2018

Event Type  Injury  

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 Description

The customer reported that during an autologous continuous mononuclear cell (cmnc)collection on the spectra optia device, a patient experienced hypertension.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 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.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information is provided.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 Description

After multiple attempts the patient id was not provided by the customer.

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 Description

The autologus patient was mobilized with grafeel 750 g/day for 5 days and 7mg of mozi for one day before the procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 8120342
• MDR Text Key: 128911340
• Report Number: 1722028-2018-00321
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103009
• UDI-Public: 05020583103009
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: 10300
• Device Lot Number: 1805293330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 11/30/2018
• Supplement Dates Manufacturer Received: 12/10/2018; 01/09/2019
• Supplement Dates FDA Received: 12/20/2018; 01/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00034 YR
• Patient Weight: 70