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 04/09/2021

Event Type  malfunction  

Event Description

Related manufacturer report number: 3003306248-2021-01104, 3003306248-2021-01110 it was reported that on (b)(6) 2021 the site performed a circuit exchange from an rvad with an oxygenator to an rvad pack without.The motor they took off the patients initial circuit was so hot to touch, including the disposable blood pump.The speed and flow at the time of change was 5400 rpms and 4lpm.The site was unsure the duration the patient was on 5400 rpms with a flow of ~4lpm.

Manufacturer Narrative

Main investigation conclusion: the reported event of a hot motor was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6)) was not returned for analysis.Good faith efforts were sent to retrieve additional information on if any additional equipment was exchanged and will be returning and if the event resolved and how; however, no response was received.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 table 13 entitled ¿console alarms & alerts¿ states when receiving a m6 motor over temp alarm to ¿switch to backup console, motor, and flow probe according to the procedure described in section 10.1.Verify that the backup motor stands free and is not covered (e.G.Blankets)¿.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: 11769977
• MDR Text Key: 253813603
• Report Number: 3003306248-2021-01103
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 71