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

Lot Number 2307216141

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/20/2023

Event Type  malfunction  

Event Description

Treatment initiated with goal for 1.0 exchange and when patient was at.7 exchange , centrifuge stopped and blood leak alarm activated.Centrifuge cover opened and blood noted in cavity of machine.Treatment ended unable to return blood.Noted tear in the centrifuge channel.Approximate blood loss approximated 240 ml.Patient asymptomatic.Patient discharged to ambulatory unit with steady gait.

• Brand Name: SPECTRA OPTIA®
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC.; 10811 w collins ave; lakewood CO 80215
• MDR Report Key: 18703554
• MDR Text Key: 335363286
• Report Number: 18703554
• 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: 01/02/2024

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 Lot Number: 2307216141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2024
• Date Report to Manufacturer: 02/14/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR