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); Pumping Problem (3016)

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

Event Date 03/24/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient was being supported by the centrimag console which was running a centrimag pump.It was reported that s3 alarm on lvad cmag console.The hospital attempted changing flow probe however unable to resolve alarm.The flow probe was tested on another console and still no resolution.The hospital was then instructed to change to back up console and motor and alarm resolved.They were also instructed to have the md in room and per the doctor¿s discretion change out lvad and manage rvad during the change out to avoid pulmonary complication.No additional information was provided.

Manufacturer Narrative

Section h4: additional information: manufactures investigation conclusion: the report of an s3 alarm was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console.At approximately 5:30pm on (b)(6) 2019 the log file captured an active system alert: s3 due to an active can bus send error fault.Once this fault occurred, the flow reading became blank at 0lpm, but the console continued to support the pump at the set speed.The s3 alarm was muted soon after activating but remained active until the console was powered down.The returned centrimag 2nd gen primary console was evaluated and tested by the service depot under work order #53651001.The reported complaint was not duplicated during testing.The unit operated a test system overnight with a test motor and flow probe.The flow probe used during the event was not returned for analysis.No s3 alarms nor any other issues were observed during testing.Full functional checkout was performed per the centrimag 2nd gen primary console service process and the unit passed all tests.The returned console was found to function as intended.As a result, the root cause of the reported event could not be conclusively determined.During testing it was noted that the console's internal battery (serial number (b)(6)) had expired on february 2014.The expired battery was replaced with a new one and battery maintenance was performed successfully.Additionally, the console's software was outdated so it was updated to the latest revision software.The serviced and tested unit was returned to the customer site.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.

Manufacturer Narrative

Additional information.Section a4: patient weight was requested but was not able to be provided.

Manufacturer Narrative

No further information was provided.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8499533
• MDR Text Key: 141465014
• Report Number: 2916596-2019-01652
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/26/2020

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 Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 06/24/2019; 07/29/2019; 02/10/2020
• Supplement Dates FDA Received: 07/11/2019; 07/30/2019; 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR