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

Model Number 201-90411

Device Problem Unexpected Shutdown (4019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

The patient's date of birth and age were not provided.The patient¿s gender was not provided.The patient¿s weight was not provided.The device was returned for investigation.The evaluation is not yet complete.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 console stopped running the pump with s3, m4 and m5 errors.The unit is being sent in for repair.Additional information was requested but have not been provided.

Manufacturer Narrative

Manufactures investigation conclusion: the reported event of s3, m4, and m5 alarms were confirmed via the log file.The centrimag 2nd generation primary console was returned for analysis and a log file was downloaded from the console.A review of the downloaded log file showed event spanning approximately 12 days ((b)(6) 2020 per time stamp).On (b)(6) 2020 at 04:34 a ¿sf_ifd_shutdown_detected¿ activated and triggered ¿system fault: s3¿, ¿set pump speed not reached: m5¿, and ¿motor alarm: m4¿ activated.The speed dropped to ~2900 rpm and the flow dropped to 0 lpm and a ¿flow signal interrupted: f2¿ alarm activated.There were no other notable alarms active in the log file.The console was returned for analysis and was evaluated and tested under work order #(b)(4).The reported event was unable to be duplicated nor verified.The console was tested with a test motor and the returned and associated flow probe.No alarms occurred at any point and the console always performed as intended.The console was returned to the customer.Reports of similar events have been documented and corrective action had been initiated to investigate the issue further.The investigation has determined that the issue is not related to a 2nd generation primary console related issue.Reports of similar events will continue to be tracked and monitored.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: 10019501
• MDR Text Key: 189919445
• Report Number: 2916596-2020-02214
• 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,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 91