MAUDE Adverse Event Report: TERUMO BCT, INC. SPECTRA OPTIA EXCHANGE SET

Lot Number 1903133230

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Chest Tightness/Pressure (2463)

Event Date 04/26/2019

Event Type  Injury  

Event Description

Pt is a sickle-cell disease pt undergoing depletion red blood cell exchange; 14 mins into the depletion phase, the pt experienced chest tightness and / or chest pain and cough.His symptoms resolved with supplemental oxygen and epinephrine.Fda safety report id# (b)(4).

• Brand Name: SPECTRA OPTIA EXCHANGE SET
• Type of Device: SPECTRA OPTIA
• Manufacturer (Section D): TERUMO BCT, INC.
• MDR Report Key: 8608260
• MDR Text Key: 145142749
• Report Number: MW5086607
• 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: Physician
• Type of Report: Initial
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 1903133230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 17 YR
• Patient Weight: 53