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

Model Number 201-90411

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Related mfr #: 3003306248-2021-01069.It was reported that the centrimag 2nd generation primary console was giving off a burning smell and the centrimag motor was hot.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a burning smell coming from the console was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6) ) was returned for analysis and a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately 4 days ((b)(6) 2021, (b)(6) 2021 ¿ (b)(6) 2021, (b)(6) 2021 per time stamp).There were no events related to the reported event active in the log file.There were no notable alarms active in the log file.The centrimag 2nd generation primary console was returned for analysis and was connected to the returned and associated centrimag motor and was run on a test loop for several days with no issues.The console was functionally tested and passed all tests before being returned to the customer.The reported event was unable to be reproduced.The root cause for the reported event was unable to be conclusively determined through this analysis.The 2nd generation centrimag system operating manual (rev.11) section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, 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 main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual (rev.11) section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual (rev.11) section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events, including b1 alarms.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: (b)(6) ) and the console was found to pass all manufacturing and qa specifications.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: 11485993
• MDR Text Key: 239823130
• Report Number: 3003306248-2021-01068
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 7351577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1