MAUDE Adverse Event Report: TERUMO BCT, INC. SPECTRA OPTIA; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Lot Number 2302133141

Device Problems Device Alarm System (1012); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2023

Event Type  malfunction  

Event Description

Procedure treatment for therapeutic plasma exchange on the optia machine with a terumo bct kit.Multiple alarms noted during procedure and terumo bct notified.Unable to clear alarms and not able to rinse back.Treatment stopped and restarted with new kit on different machine.Manufacturer response for terumo bct, (brand not provided) (per site reporter) the manufacturer exchanged the device.

• Brand Name: SPECTRA OPTIA
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC.; 10811 west collins ave.; lakewood CO 80215
• MDR Report Key: 16918443
• MDR Text Key: 315087010
• Report Number: 16918443
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/05/2023

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 Lot Number: 2302133141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/05/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/12/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Weight: 56 KG
• Patient Race: White