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

Model Number 201-90411

Device Problems Insufficient Information (3190); Unexpected Shutdown (4019)

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

Event Date 03/08/2021

Event Type  malfunction  

Event Description

Related manufacturer¿s report #3003306248-2021-01083.It was reported that the site had a centrimag motor and console fail while attached to the patient.The console had message motor disconnected after the motor had stopped running.

Manufacturer Narrative

Section d4: expiration date was inadvertently reported in initial report and is not applicable for this device.Manufacturer's investigation conclusion: the reported event of a motor disconnected alarm and the motor stopping 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 3 days ((b)(6) 2021 per time stamp).Events occurring on (b)(6) 2021 took place during lab testing at abbott.There were no events related to the reported event active in the log file.The motor was at a speed of 0 rpm and a flow of 0 lpm throughout the entire log file.The centrimag 2nd generation primary console was returned for analysis and was tested with the returned and associated centrimag motor as well as a test motor and flow probe for an extended period of time, including overnight.The console was able to keep the motor at the set speed and flow.No issues or alarms were observed, and pump operation was not affected.A full functional checkout was performed, and the console operated as intended.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 m2 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 i s 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: 11576470
• MDR Text Key: 245988642
• Report Number: 3003306248-2021-01084
• 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: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6141145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/26/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 167