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

Lot Number 2211216241

Patient Problem Insufficient Information (4580)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

Patient was undergoing apheresis stem cell collection.Healthcare providers identified return pressure alarms with poor flow.Unable to obtain blood flow greater than 50-60ml/min.Flushing, reversing and repositioning of patient was attempted without change to.Upon inspection of tubing during attempts at fixing return flow, identified hermetic seal on return line.New kit set-up/primed.No other experienced once kit changed.

• 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: 18147602
• MDR Text Key: 328260671
• Report Number: 18147602
• 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: 09/23/2023,09/22/2023

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 Lot Number: 2211216241
• 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: 09/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Male
• Patient Weight: 93 KG