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

Model Number 12220

Device Problems Fluid/Blood Leak (1250); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2022

Event Type  malfunction  

Event Description

At the completion of the apheresis treatment, the nurse opened the centrifuge chamber to find blood spray inside the chamber.Fluid leak detector alarm did not sound during procedure.Unable to find defect through visual examination on kit although photos of incident suggest that the leak happened at the connector site on the channel.

• Brand Name: SPECTRA OPTIA®
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC.; 10810 west collins avenue; lakewood CO 80215
• MDR Report Key: 15833364
• MDR Text Key: 304018510
• Report Number: 15833364
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12220
• Device Lot Number: 2204216141
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2022
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White