MAUDE Adverse Event Report: TERUMO BCT INC. TERUMO SPECTRA OPTIA

Device Problem Insufficient Information (3190)

Patient Problems Apheresis (1719); Fever (1858)

Event Date 02/08/2018

Event Type  Injury  

Event Description

Patient had a fever post central line placement, red cell prime and apheresis collection for car t cell therapy (kymriah).

• Brand Name: TERUMO SPECTRA OPTIA
• Type of Device: OPTIA
• Manufacturer (Section D): TERUMO BCT INC.
• MDR Report Key: 7334325
• MDR Text Key: 102345007
• Report Number: MW5075833
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 42