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

Lot Number OPTIA EXCHANGE KIT 2010233130

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

Patient Problems Cardiac Arrest (1762); Chest Pain (1776)

Event Date 02/22/2021

Event Type  Injury  

Event Description

During therapeutic plasma exchange for heart transplant rejection, patient developed chest pain and went into cardiac arrest.The patient had presented to the hospital with chest pain and had known, progressive, transplant associated coronary artery disease.He had undergone 4 previous therapeutic plasma exchange in the preceding days without incidence.Fda safety report id# (b)(4).

• Brand Name: TERUMOBCT SPECTRA OPTIA
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11453115
• MDR Text Key: 239137547
• Report Number: MW5099873
• Device Sequence Number: 1
• Product Code: GKT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Lot Number: OPTIA EXCHANGE KIT 2010233130
• 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): Life Threatening
• Patient Age: 48 YR
• Patient Weight: 91