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

Model Number 102954

Device Problems Noise, Audible (3273); Excessive Heating (4030)

Patient Problem Thrombus (2101)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

The centrimag motor was captured under mfr# 2916596-2019-03827.The centrimag blood pump was captured under mfr# 2916596-2019-03835.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with an extracorporeal circulatory support pump on (b)(6) 2019.It was reported that the patient was in cardiogenic shock and was initiated on dual centrimag acute support with an oxygenator attached to the right-sided support.Going into the intensive care unit (icu), the left ventricular assist device (lvad) was set at 4000 with 4.7lpm flow and the right vad was set at 2700 with 4lpm flow.Approximately an hour after getting into the icu from the operating room, the cardiologist received an s3 alarm with a loud noise coming from the motor and pump on the lvad and that the motor was hot to the touch.Healthcare professionals immediately switched to the backup motor and there have been no alarms since.The patient was in critical health status due to being in shock and not due to the event.It was also reported that there was additional incident on (b)(6) 2019 in the evening following the switch to full backup system due to rattling sound from pump and s3 alarm.No further alarms have occurred since the switch to full backup system.Photos were provided of the pump secured in the motor on the new system to ensure secure pump placement.On (b)(6) 2019, the patient experienced significant flow fluctuations and apparent suck down at drainage cannula.Volume was given to the patient but flow fluctuations persisted.The patient was taken to the catheterization lab where a "huge left ventricle thrombus" was identified.This was thought to be the cause of the drop in flow and flow fluctuations and the patient was otherwise doing fine.Treatment for the thrombus was to explant the centrimag and implant with a heartmate 3 lvad on (b)(6) 2019.The centrimag console was added as a result of the investigation that concluded other causes may have contributed to the reported events besides thrombus.

Manufacturer Narrative

Section d4: the serial number of the centrimag 1st generation primary console was requested but was not provided.Manufacturer's investigation conclusion: the reported event of a s3 alarm was not confirmed.The centrimag 1st generation primary console was not returned for analysis and no additional information regarding the console was provided.The root cause for the reported s3 alarm was unable to be conclusively determined through this analysis.Centrimag motor instructions for use instructs to always have a back-up centrimag motor available.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: 9576361
• MDR Text Key: 176011415
• Report Number: 2916596-2020-00153
• 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: other
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

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: Lay User/Patient
• Device Model Number: 102954
• Device Catalogue Number: 102954
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 111