MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH PRIM CONS 1ST GEN, STANDALONE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30100

Device Problems Alarm Not Visible (1022); Display or Visual Feedback Problem (1184)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

This event occurred at (b)(6).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

Related manufacturer report number: 3003306248-2020-00040.It was reported that the patient had recently been converted from venoarterial extracorporeal membrane oxygenation (va-ecmo) to centrimag left ventricular assist device (lvad) support.On (b)(6) 2020 the centrimag system stopped, there was a loss of rotational speed at the motor.Circulatory support was interrupted and the patient hemodynamically deteriorated which necessitated cpr to restore acceptable circulation.The physicians were unable to restore power to the centrimag motor due to a missing set rpm option on the screen of the primary console.The whole centrimag system was exchanged for a backup one.It was also noted that the centrimag motor was extremely hot during the event.After exchange to the backup centrimag system, circulatory support was re-established and the patient hemodynamically stabilized.The physicians reportedly did not remember any active alarms during the event.

Manufacturer Narrative

Section h3, h4: additional information.Manufacturer's investigation conclusion: the reported event of the system stopping and being unable to restore motor speed was not confirmed.The centrimag 1st generation primary console (serial #: (b)(6)) was returned for analysis to the edc and was evaluated and tested.The console was powered on as intended and was functionally tested for 6 days.The console always functioned as intended.The reported event was unable to be reproduced.The console was returned to the customer.The root cause for the reported event was unable to be conclusively determined through this analysis.The centrimag motor instructions for use (ifu) instructs to always have a back-up centrimag motor available.The centrimag blood pump ifu states "always have a spare centrimag blood pump, back-up console and equipment available for change out".Additionally, the centrimag primary console operating manual warns "one back-up console and motor are required in the immediate vicinity of each patient whenever the centrimag blood pump is used.The back-up console must be connected to the back-up motor, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the primary console or primary motor experience a malfunction." no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: PRIM CONS 1ST GEN, STANDALONE
• 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: 10101597
• MDR Text Key: 194132487
• Report Number: 3003306248-2020-00039
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

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: 201-30100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, OUS
• Patient Outcome(s): Life Threatening; Required Intervention