MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 102954

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

Patient Problem Cardiogenic Shock (2262)

Event Date 09/26/2020

Event Type  Death  

Manufacturer Narrative

The patient¿s gender was not provided.The patient¿s weight was not provided.The investigation results will be provided in the final report.

Event Description

It was reported that the patient passed away on (b)(6) 2020 due to cardiogenic shock.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported patient outcome could not be determined through this evaluation.It was reported via patient outcome that the patient passed away due to cardiogenic shock.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) (rev.09) lists death as an adverse event that may be associated with the centrimag circulatory support system under ¿adverse events.¿ 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.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 1ST GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 11389032
• MDR Text Key: 233891044
• Report Number: 3003306248-2021-00559
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K093832
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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: 102954
• Device Catalogue Number: 102954
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR