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 Fever (1858); Vomiting (2144); No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2018

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 allogenic continuous mononuclear cell (cmnc) collection on the spectra optia device, a donor experienced shivering, vomiting and minor fever.Per the customer, this donor reaction occured after one total blood volume (tbv) of the patient was processed.The doctor at the customer site ordered iv avil injection, bolos iv calcium, iv magnesium sulphate, iv paracetamol and iv ranitidine injection as a result of the reaction.Per the customer, the donor is reported as "ok".Donor¿s age and identifier are 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.Root cause: a definitive root cause for the donor's reaction could not be determined.Possible causes for the alleged reactions include but are not limited to the donor's physiology, drugs used for mobilization, medication used in the procedure and/or the patient's sensitivity to et0.

Event Description

After multiple attempts the donor 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 autologous donor was mobilized with grafeel 900 g/day for 5 days and also given mozi for 24mg 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: 8120239
• MDR Text Key: 128907188
• Report Number: 1722028-2018-00315
• 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: 1805043130
• 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
• Date Device Manufactured: 05/04/2018
• 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: 00057 YR
• Patient Weight: 83