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

Model Number P102624

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/01/2022

Event Type  malfunction  

Event Description

156 minutes into the apheresis treatment with filtration plasmapheresis (ffp) machine, it alarmed of a blood leak.A blood leak was confirmed at the inlet port of the centrifuge chamber.Treatment was terminated without rinse back of blood in the system.Estimated blood loss was 225 ml.The patient's hemoglobin and hematocrit were stable and vital signs were stable at discharge.Terumo was notified of the kit issue and lot number.

• Brand Name: SPECTRA OPTIA®
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC.; 10811 west collins avenue; lakewood CO 80215
• MDR Report Key: 15814678
• MDR Text Key: 303823590
• Report Number: 15814678
• 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: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P102624
• Device Lot Number: 2208303230
• 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: 10/25/2022
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14600 DA
• Patient Sex: Male
• Patient Weight: 173 KG
• Patient Race: White