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

Model Number 000000000000061000

Device Problems Incorrect Or Inadequate Test Results (2456); High Test Results (2457)

Patient Problem Seizures (2063)

Event Date 01/28/2014

Event Type  Injury  

Event Description

The customer reported that an operator may have entered the incorrect replacement hematocrit (hct) as 28% instead of 58% during a red blood cell exchange (rbcx) procedure.Approximately 40 minutes after the procedure, the patient developed seizures and was transported to intensive care unit with sedation and intubation.After the procedure, the patient's hematocrit was elevated from 28% to 48%, and the hemaglobin level increased to 16.5 g/dl.A physician performed multiple manual venesection and lowered the patient's hemaglobin to 9.2 g/dl.The customer declined to provide patient's age.The disposable set is unavailable for return because the customer discarded it.This report is being filed due to medical intervention via hospitalization, sedation, intubation, and manual venesection.

Manufacturer Narrative

Investigation evaluation and corrective actions are in-process.A follow-up report will be provided.

Manufacturer Narrative

There was no on-site service associated with this record, as the customer indicated that the problem resulted from incorrect data entry.No machine problem was alleged or suspected.The machine has been in use with no further occurrences of the problem.A review of the last year of service history for this device indicated no other reports related to this issue.The run data file (rdf) was reviewed for this event.Per the rdf, the replacement hct was entered at 30% and according to the customer, the actual replacement hct was 58%.If the replacement hct was entered with this much error it would explain why the patients end hct was 48% instead of 28%.Entry of incorrect values will result in incorrect end targets.The outcome of the procedure depends on the accuracy of the data entered.Root cause: the root cause of the reported problem was incorrect entry of the hematocrit for the replacement red cells by the operator.A report of operator error issues is distributed each quarter to sales and implementation for potential targeted training.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury of the mdr form.This supplement is being filed to modify information per fda request.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3645468
• MDR Text Key: 4287750
• Report Number: 1722028-2014-00065
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: BK120012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2014

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 Model Number: 000000000000061000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2014
• Initial Date FDA Received: 02/25/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/25/2014; 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 61