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

Model Number 201-90411

Device Problems Pumping Stopped (1503); Calibration Problem (2890); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Related manufacturer's report number: (b)(4).It was reported that the cmag console suddenly lost flow readings from the console display.The flow probe was checked on a different console and worked fine.It was reported that the motor rpms dropped to zero.The console appeared to reset, and display a calibration message.The patient was swapped over to a backup generation 2 console with the same motor, and it ran normally.The patient was not harmed by this event.A service loaner has been requested.The console will be returned for investigation.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of no flow readings and the motor speed dropping was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis and a log file was downloaded for review with events spanning approximately 5 days ((b)(6) 2020 ¿ (b)(6) 2020 per time stamp).The console was running a motor at a speed of ~700 rpm with a flow of ~2.31 lpm.The reported event date was not captured in the log file.The flow was always displayed when the flow probe was connected.The motor speed never dropped.There were no notable alarms active in the log file.Pump operation was not affected.The centrimag 2nd generation primary was evaluated and tested under work order #(b)(6).The reported event was unable to be duplicated or verified.The console was tested with a test motor and returned and associated flow probe.The unit was checked at every specified rpm and flow speed and found no issues with the flow at any point.A full functional checkout was performed, and the unit passed all tests.The console was returned to the customer.The root cause for the reported event was unable to be conclusively determined through this analysis.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: 10140805
• MDR Text Key: 214353762
• Report Number: 3003306248-2020-00041
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• 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 Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, US
• Patient Age: 74 YR