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

Catalog Number 12220

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 09/13/2020

Event Type  malfunction  

Event Description

While priming the plex apheresis cassette, tubing was noted to be leaking from the area near where the tubing enters the cassette.There was leaking from one piece of tubing only (not both).

• Brand Name: SPECTRA OPTIA
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC.; 10811 w. collins avenue; lakewood CO 80215
• MDR Report Key: 10829103
• MDR Text Key: 215934685
• Report Number: 10829103
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12220
• Device Lot Number: 2003123330
• 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: 09/28/2020
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16790 DA