MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Catalog Number 10220

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  

Manufacturer Narrative

Investigation: a disposable history search confirmed there were no occurrences of a similar issue reported on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The patient reaction and subsequent death is believed to be related to disease progression root cause: the root cause of the cardiac arrest was due to the patient's underlying condition.

Event Description

Terumo bct received medwatch 5099873 with the following incident 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 exchanges in the preceding days without incident.Fda safety report id# (b)(4)" icu team initiated code procedures following the cardiac arrest.The patient was placed on extracorporeal membrane oxygenation (ecmo) and died 3 weeks later.The disposable set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 11770547
• MDR Text Key: 249008777
• Report Number: 1722028-2021-00170
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• 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 Catalogue Number: 10220
• Device Lot Number: 2010233130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00048 YR
• Patient Weight: 94