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

Model Number 201-30300

Device Problem Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Date 10/28/2019

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

It was reported that s3 alarm occurred and failed to start battery maintenance.The centrimag (cmag) console was plugged into a different cmag motor and the issue continued.Problems were found during preventive maintenance.

Manufacturer Narrative

Section d3 and g2: correction.

Manufacturer Narrative

Section d5 and h1: correction section d10, h3, and h4: additional information section g4 was inadvertently left out of the previous supplemental report.The correct date received by manufacturer was 05mar2020.Manufacturer's investigation conclusion: the reported event of a s3 alarm before battery maintenance was confirmed via the log file.The centrimag 2nd generation primary console was returned for analysis and a log file was downloaded from the console for review.A review of the log file showed a ¿system alert: s3¿ alarm active on(b)(6)2019 at 15:33 which was triggered by the sub fault ¿sf_sps_speaker_current_2¿.The s3 alarm occurred twice after starting the console up on battery power.On(b)(6)2019 the console was started up on mains power the s3 alert alarmed immediately after bios maintence was initiated.The console was switched on and off several times and the s3 alarm always reoccurred.The centrimag 2nd generation primary console was returned for analysis to the edc belgium and was evaluated.On (b)(6)2020 the console¿s speakers operated as intended; however, the console was forwarded to mcs zurich and was evaluated and tested.The console was powered on using battery power and started up as intended; both speakers were heard and no s3 alarms were active.The console was opened, and the two speaker cables were inspected and tested, and no issues were found.The console was functionally tested with a test flow probe and motor at 5000 rpm/9 lpm for 5 hours and always operated as intended.As a preventative measure, the speakers and sps pcb were replaced.The console was subjected to the repair and maintenance procedure and all tests.The console was forwarded to the distribution center to be sent back to the customer.The root cause of the s3 alarm was conclusively determined to be due to only one of the two alarms alarming during power on; however, the root cause of only one alarm alarming was not conclusively determined through this analysis.The 2nd generation centrimag system operating manual 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 section 7.6 entitled ¿self-test initiation¿ states to verify the two audio beepers sound during the self-test and to turn off the console if they do not sound.Check all the power and cable connections and reboot.If the console does not boot correctly, replace the console with another.The 2nd generation centrimag system operating manual 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 has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a 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 back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.The 2nd generation centrimag system operating manual 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.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 CA CH-80 05; SZ CH-8005
• MDR Report Key: 9305223
• MDR Text Key: 165997797
• Report Number: 2916596-2019-05206
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2020

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: 201-30300
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 10/28/2019; 05/22/2020
• Supplement Dates FDA Received: 03/06/2020; 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1