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 Death (1802); Myocardial Infarction (1969); Cardiogenic Shock (2262)

Event Date 10/24/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported through the patient outcome, the patient expired due to post mi; ischemic cardiogenic shock requiring extracorporeal membrane oxygenation (ecmo) and transition to centri-mag.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the centrimag blood pump and the reported events could not conclusively be established through this evaluation.Although a specific cause for the reported myocardical infarction could not be determined through this evaluation, it was reported by the account that the patient's death was not considered to be device-related, and that the device operated as expected.The device will not be returned for evaluation.Multiple requests for additional information, including the lot number of the device, have been sent to the customer; however, no response has been received at this time.Centrimag blood pump instructions for use (ifu) was released in (b)(6) 2019.Death and myocardial infarction are listed as adverse events that may be associated with the use on the centrimag ventricular assist device (vad).It also contains the following warnings and precautions: 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.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: 10501200
• MDR Text Key: 205884774
• Report Number: 2916596-2020-04099
• Device Sequence Number: 1
• Product Code: KFM
• 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: 03/22/2021

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 Model Number: 102953
• Device Catalogue Number: 102953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 03/16/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 69