MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Catalog Number 61000

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Weakness (2145)

Event Date 07/10/2017

Event Type  Injury  

Manufacturer Narrative

Additional (b)(4).Investigation: per the customer, the hospital uses a replacement hematocrit (hct)between 55% and 60%.Per the nurse manager, she believes that the patient was hydrated with saline to lower her hematocrit less than 40%.The run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the spectra optia system operated as intended.Based on the information provided by the customer, the replacement fluid hct should have been entered as 60% instead of 30%.The higher than expected patient hct at the end of the procedure could have been due to the discrepancy between the actual and the entered replacement fluid hct.When the replacement fluid hct is entered falsely low, there are more rbcs being returned to the patient than the spectra optia system expects which could result in a higher than expected end patient hct.A service call was placed and a full machine checkout was performed.Near the end of a stimulated use testing, the service technician noted that the sealer was not functioning.The seal safe coiled cable was replaced and it was verified that the sealer was sealing the tubing line properly.During the functional machine checkout, the service technician verified the pressure sensors,touchscreen sensors, and all pump rollers on the pump rotors and all were within manufacturing specifications.The service technician also verified pump 4 and pump 5 were occluding properly and all valves were torqued per manufacturing specifications.Aim startup and post startup test was successfully completed.An autotest and saline run were successfully performed.The machine is functioning per manufacturer's specification.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that after a red blood cell exchange (rbcx) procedure, the patient's post hematocrit (hct) was higher than what was programmed.The patient's beginning hct was 23.9% and the programmed end hct was 30%.Approximately 12 hours post procedure, the patient was re-admitted to the hospital due to feeling weakness on the left side of her body.Per the attending physician order, the patient's hematocrit was drawn.Test results indicated that the patient's hct was 40% and she experienced a stroke.The patient is reported in full recovery.Per the customer, no issues occurred during the rbcx procedure.The customer declined to provide patient identifier and age.The rbcx set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Root cause: a definitive root cause for the donor's reaction could not be determined.The signals in the run data file indicate that the spectra optia system operated as intended.Based on the information provided by the customer, the replacement fluid hct should have been entered as 60% instead of 30%.It is possible, but not confirmed, that the higher than expected patient hct at the end of the procedure could have been due to the discrepancy between the actual and the entered replacement fluid hct.When the replacement fluid hct is entered falsely low, there are more rbcs being returned to the patient than the spectra optia system expects which could result in a higher than expected end patient hct.Other possible causes for the reaction include but are not limited to donor's physiology and/or donor's sensitivity to the procedure.

Manufacturer Narrative

This report is being filed to provide additional information.

Manufacturer Narrative

This report is being filed to provide additional information.Additional investigation: the device serial number history report indicates no further related issues have been reported for this device.Per terumo bct internal medical review process, it was determined that the device could have been a contributor to the reported issue, however, not through abnormal operation.The cause of injury was determined to be the operator's incorrect entry of the replacement hct, compounded by a failure to understand why the procedure would not run within the parameters that were entered.The optia system operated as intended according to the data entered and alarmed indicating potential data entry error, which was not addressed by the operator.

Manufacturer Narrative

This report is being filed to provide corrected information and additional information.Additional investigation: a device check out was performed by a terumo bct service representative.The machine was found to be fully functional with the exception of an inoperable rf sealer which has no impact on the reported condition.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: according to aabb technical manual 16th edition, adverse events seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 3400 donors and some donors with severe reactions may need intravenous fluid administration in the emergency room.One year of service history was reviewed for this device with no issues related to the reported condition identified.Investigation is in process.A follow-up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6767388
• MDR Text Key: 81831361
• Report Number: 1722028-2017-00314
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK140151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/04/2017

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: 03/01/2019
• Device Catalogue Number: 61000
• Device Lot Number: 03A3101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 04/03/2018; 05/08/2018; 06/15/2018; 08/09/2018; 08/14/2018
• Supplement Dates FDA Received: 04/13/2018; 05/08/2018; 06/22/2018; 08/10/2018; 08/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2015
• 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): Required Intervention
• Patient Weight: 66