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

Model Number 1PO2623

Device Problems Fluid/Blood Leak (1250); Material Frayed (1262)

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

Event Date 10/03/2022

Event Type  malfunction  

Event Description

Twenty-two minutes into the procedure, the drive line tubing frayed below the proximal bearing retainer resulting in blood leak.Proper protocol followed and treatment was terminated immediately with an estimated blood loss (ebl) of 225ml.H/h above normal limits causing no concern regarding blood loss.Md notified of event.New machine set up with different kit lot number due to this being the second event of tubing malfunction with the same lot number.Treatment continued and completed without further events.Patient discharged after treatment completion in stable condition.Terumo notified of kit malfunction.

• 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: 15804850
• MDR Text Key: 303722854
• Report Number: 15804850
• 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: 10/25/2022,10/17/2022

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 Model Number: 1PO2623
• Device Lot Number: 2208303230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• 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: 11/16/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2022
• 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