MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90401

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2020

Event Type  Injury  

Manufacturer Narrative

The cause of this event is not conclusive and is also reported in cmag motor under mfr #2916596-2020-00544.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 patient was in the intensive care unit (icu).The pressure cable from the centrimag (cmag) console was accidentally disconnected by the clinical team.The cmag console subsequently alarmed showing s3 alarm.The primary cmag console was switched with a backup console.

Manufacturer Narrative

H4: additional information.Manufacturer's investigation conclusion: the reported event of an s3 alarm was confirmed.The returned centrimag console (serial number was tested at the european distribution center (edc) on 14feb2020.The console was functionally tested and always operated as intended during testing.The console was returned to the customer site after passing all tests per procedure.Although the reported event was not reproduced, a log file was extracted from the console during testing which captured an active s3 alarm on (b)(6) 2020 at 16:15, which was triggered by an active ¿can bus send error¿ sub-fault.The log file was forwarded to the ppe department for further review.Per the log file, on (b)(6) 2020, the console was supporting the system at a speed of ~3500 rpm and a flow of ~2.6 lpm.A ¿can bus send error¿ became active at 16:15, triggering a system alert: s3 alarm.At this time the motor was also captured as disconnected and speed dropped to 0 rpm.The motor was then captured as reconnected at 16:16 and ramped up to a speed of ~3000 rpm over several minutes; however, the flow value reading remained captured as 0 lpm throughout the remainder of the log file due to the can bus error.The system was shut down on (b)(6) 2020 at 21:35 in order to conduct the reported console exchange.No other notable events were observed throughout the log file.Because the console operated as intended during testing, the root cause of the reported event was unable to be conclusively determined through this analysis.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual 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." it also 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 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 WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
• 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: 9660589
• MDR Text Key: 177934139
• Report Number: 2916596-2020-00379
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90401
• Device Lot Number: 6224746
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1