MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102953

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

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/29/2019

Event Type  Death  

Event Description

It was reported that the patient passed away due to multi-system organ failure.

Manufacturer Narrative

Section a: multiple attempts were made to obtain additional information from the customer regarding the event (including gender and weight); however, no additional information was provided.Manufacturer's investigation conclusion: a direct correlation between the device and the reported patient outcome could not be determined through this evaluation.Multiple requests for additional information were sent to the customer; however, no response has been received at this time.The centrimag blood pump instructions for use (ifu) lists death as an adverse event that may be associated with the centrimag circulatory support system under ¿adverse events.¿ in addition, this ifu lists multiple types of organ failure and dysfunction (hepatic dysfunction, renal dysfunction, respiratory failure, and right heart failure) as adverse events that may be associated with the centrimag circulatory support system.Review of the device history record (dhr) for the centrimag blood pump (dhr cm pump (b)(6) revealed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) lists death as an adverse event that may be associated with the centrimag circulatory support system under ¿adverse events.¿ in addition, this ifu lists multiple types of organ failure and dysfunction (hepatic dysfunction, renal dysfunction, respiratory failure, and right heart failure) as adverse events that may be associated with the centrimag circulatory support system.This ifu also provides the following warnings and cautions: ifu warning #1: carefully read all warnings, precautions, manuals, and instructions for use for this and all related thoratec extracorporeal devices prior to use.Failure to read and follow all instruction, or failure to observe all stated warnings, could cause serious injury or death to the patient.Ifu warming #10: frequent patient and device monitoring is recommended.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 11397870
• MDR Text Key: 234205804
• Report Number: 3003306248-2021-00554
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

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: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 45 YR