MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO FX15-30; OXYGENATOR, CARDIOPULMONARY BYPASS

Lot Number YK03

Device Problem Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/13/2021

Event Type  malfunction  

Event Description

Surgeon requested a target temperature of 28c after ep (electrophysiology study) mapping.There was concern for the right sided nirs (near-infrared spectroscopy) which were 62 with a left sided nirs of 78.Surgeon elected to cool to 18c.Four hours on bypass, apparent fibrin formation was noted in the oxygenator bundle/arterial filter area.The venous filter and the cardiotomy filter both appeared to have clot propagating higher in their respective areas.A teg (thromboelastography) was sent (which eventually resulted as hypocoagulable).The decision was made to change the entire circuit out under circulatory arrest.This was done in three minutes with the left nirs going from 94 to 92 and the right nirs going from 89 to 82.The oxygenator device was a terumo fx 15-30 with lot# yk03.Possible fibrin formation in bypass circuit oxygenator, possibly after arterial filter.It is unclear if this is a patient related issue or an equipment issue.

• Brand Name: TERUMO FX15-30
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• MDR Report Key: 13677686
• MDR Text Key: 286649939
• Report Number: 13677686
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: YK03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4745 DA
• Patient Sex: Male
• Patient Weight: 48 KG