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

Model Number L201-90401

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 01/14/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that a patient on the centrimag had normal pressures, the site was preparing to move the patient from the icu to ir for embolization (lung bleeds).It was reported that there was an s3 alarm, there were no reported pump stoppages.It was noted that the patient became hypotensive, which was corrected after the pump change.It was reported that the patient was still on vva-ecmo and was anesthetized due to the vva-ecmo therapy.The console was exchanged.No additional information was provided.

Event Description

Related manufacturer report number: 003306248-2021-00021.

Manufacturer Narrative

Manufacturer's investigation conclusion: the the reported event of a s3 alarm was confirmed via the log file.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis and a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately 3 days ((b)(6) 2021 ¿ (b)(6) 2021, (b)(6) 2021 per time stamp).Events occurring on (b)(6) 2021 took place during lab testing at abbott.On (b)(6) 2021 at 13:17:27 a flow below minimum: f3 activated followed by a motor disconnected: m2 alarm at 13:17:28, indicating the motor was disconnected dropping the speed to 0 rpm.A tech flow error: can bus send error activated 13:17:29 triggering a system alert: s3 alarm at 13:17:31 the flow dropped to 0 lpm.The motor was increased to 2400 rpm by 13:18:25.At 13:18:40 a pump not inserted: m3 alarm activated and the pump speed went back down to 0 rpm.Flow signal interrupted: f2 alarms activated from 13:19:08 to 13:21:51 and the flow probe was disconnected at 13:22:52.The console was powered cycled at 13:24:43.The s3 alarm did not recur.The centrimag 2nd generation primary console was returned for analysis to the european distribution center (edc) and was functionally tested with the returned and associated flow probe and operated as intended.The reported event was unable to be reproduced during testing.Following a successful battery maintenance and preventative maintenance the unit was returned to the customer.Additional provided information communicated on (b)(6) 2021 stated that the console was exchanged after alarming and the flow probe was showing directional arrows but had no other apparent issues.The patient was anaesthetized and therefore only had transient hypotension.The pump was not exchanged.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: (b)(6)) and the console was found to pass all manufacturing and quality assurance specifications prior to being shipped to the customer on (b)(6) 2016.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 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 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 WITH EM-TEC ADULT FLOW PROBE, OUS
• 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: 11303305
• MDR Text Key: 231113533
• Report Number: 3003306248-2021-00020
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L201-90401
• Device Lot Number: 6320476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR
• Patient Outcome(s): Required Intervention