MAUDE Adverse Event Report: TERUMO BCT, INC. TERUMO SPECTRA OPTIA APHERESIS SYSTEM TUBING; SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC

Lot Number 2203033130

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2022

Event Type  Injury  

Event Description

Blood leak in plasmapheresis tubing during procedure.This is the 3rd time this recently happened using this type of tubing during this procedure.Fda safety report id # (b)(4).

• Brand Name: TERUMO SPECTRA OPTIA APHERESIS SYSTEM TUBING
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
• Manufacturer (Section D): TERUMO BCT, INC.
• MDR Report Key: 13966607
• MDR Text Key: 288374531
• Report Number: MW5108655
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/28/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Lot Number: 2203033130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White