MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90411

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

Patient Problems Death (1802); Multiple Organ Failure (3261)

Event Date 12/21/2019

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 that the patient expired.The patient's cause of death was worsening shock and multisystem organ failure.Hm3 and the centrimag were functioning but patient continued to deteriorate.No further or additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag motor and 2nd gen primary console used during the reported event were not returned for analysis.Requests for product return and device information were sent and it was reported that no product would be returned as both the heartmate 3 and centrimag systems operated as intended.It was also reported that the serial numbers of the devices used during the event would not be provided.As a result, the root cause of the reported patient death could not be correlated to a device related issue.It was reported that the cause of death was worsening shock and multisystem organ failure.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND 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: 9606570
• MDR Text Key: 175632697
• Report Number: 2916596-2020-00279
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

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: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Weight: 86