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

Model Number 61000

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: per customer, the acd-a is used as an anticoagulant with ratio of 671 ml acto patient 132 ml with fluid balance (fb) set at 100 percent of tbv of 5180 ml.Investigation is in-process.A follow-up report will be provided.

Event Description

The customer reported that a patient with a total blood volume (tbv) of 5180 ml underwent a therapeutic plasma exchange (tpe) procedure.The procedure was successfully completed with no alarms and rinseback was performed.Per the customer, the total plasma removed was 5188 ml with replacement volume of 3955 ml and ac to patient of 132 ml.The patient is reported in stable condition.The patient identifier (id) and age are not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information.

Event Description

The customer did not provide patient id for the reported event.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Based on internal risk evaluation documentation for hypovolemia risk for incorrect filler use, the population at risk is only those patients with total blood volumes (tbvs) between 1200ml and 1700ml.It was determined that the patient's (tbv) for this event was 5180ml and therefore risk was determined to be low.One year of service history was reviewed for this device with no issues related to the reported condition identified.The device serial number history report indicates no further related issues have been reported for this device.Root cause: the root cause was determined to be a user interface issue.

• 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: 7527006
• MDR Text Key: 109048608
• Report Number: 1722028-2018-00140
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• 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
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61000
• Other Device ID Number: 05020583610002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 06/28/2018; 08/01/2018
• Supplement Dates FDA Received: 07/06/2018; 08/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00048 YR
• Patient Weight: 86