MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-90010

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

Patient Problems Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/15/2021

Event Type  Injury  

Event Description

It was reported that the patient passed away from multi organ failure.The patient had right heart failure after heartmate 3 implant requiring centrimag on (b)(6) 2021 because extracorporeal membrane oxygenation (ecmo) weaning was impossible.Heartmate 3 lvas implant kit referenced in manufacturer report number # 2916596-2021-06991.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Section h6: health effect - clinical code: multiple organ dysfunction syndrome.Manufacturer's investigation conclusion: a specific cause for the reported events as well as a direct correlation to centrimag blood pump, lot number l06832-la2, could not conclusively be determined through this evaluation.The device will not be returned for evaluation and an autopsy was not performed.The relevant sections of the device history records for l06832-la2 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump ous instructions for use (ifu) document is currently available.Warning 3: back-up components must always be available.Warning 9: possible side effects include, but are not limited to: infection, mechanical failure, hemolysis, end organ dysfunction, neurologic dysfunction, bleeding, and embolic phenomena.These are potential side effects with all mechanical circulatory support systems no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP CASE (VAS/ECMO), OUS
• 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
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12956576
• MDR Text Key: 286445716
• Report Number: 3003306248-2021-07034
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

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: Health Professional
• Device Expiration Date: 07/03/2023
• Device Model Number: 201-90010
• Device Catalogue Number: 102953
• Device Lot Number: L06832-LA2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2020
• 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): Required Intervention; Hospitalization
• Patient Weight: 88 KG