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

Model Number 201-30300

Device Problems Display or Visual Feedback Problem (1184); Incorrect, Inadequate or Imprecise Result or Readings (1535); Vibration (1674)

Patient Problem No Patient Involvement (2645)

Event Date 09/07/2019

Event Type  Injury  

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 centrimag motor was vibrating, a flow sensor fault occurred, the console display blanked then returned, and there was reduced flow from the system.The account exchanged to the backup system to which normal support resumed.No further information was provided.

Manufacturer Narrative

Section d3, g1, and g2: correction.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Section h4: additional information manufacturer's investigation conclusion: the reported event of a flow sensor fault with a blank flow reading was confirmed, however it was revealed that the centrimag 2nd gen.Primary console was unrelated to the root cause of the event.The returned centrimag console (serial number (b)(6) ) was functionally tested on (b)(6)2020.The console operated as intended when in use with a test centrimag motor.The serviced and tested console was returned to the customer site after all tests were performed per procedure.It was revealed that the root cause of the reported event was related to the returned centrimag motor.The motor¿s evaluation along with the log file associated with this event have been addressed via mfr #2916596-2019-05141.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 CA CH-80 05; SZ CH-8005
• MDR Report Key: 9260763
• MDR Text Key: 164465997
• Report Number: 2916596-2019-05142
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1