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 Infusion or Flow Problem (2964)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

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 report number: (b)(4).It was reported that when the patient was connected to the centrimag motor, and console, there was a flow alarm.The pump appeared to work, but there looked to be a negative flow.The motor did not have enough power to overcome arterial pressure.The motor, and console were changed to the backup.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of flow alarms and negative flow was confirmed via the log file.The centrimag 2nd generation console (serial #: l04913-0006) was returned for analysis, and a log file was downloaded for review.A review of the downloaded log file showed events spanning approximately 5 days ((b)(6 2020) per time stamp).Events occurring on 1(b)(6) 2020 took place during lab testing at abbott.On (b)(6)2020 at 13:31:47, the motor speed was changed to 1600 rpm and the flow began to decrease close to zero became negative occasionally.On (b)(6) 2020 at 13:45:44, 13:5:22, and at 13:53:17 a ¿flow below minimum: f3¿ alarm activated and was able to be muted and cleared.The console was powered down on (b)(6) 2020 at 14:25:17.There were no other notable alarms active in the log file.Pump operation was not affected.The centrimag 2nd generation console was returned for analysis to the european distribution center (edc).The console was tested with a test motor, flow probe, and mock loop and functioned as intended.Preventative maintenance was performed, and the unit passed all tests.The reported event was unable to be reproduced.The console was returned to the rental pool.The root cause for the reported event was unable to be 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 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.The device history records were reviewed for the centrimag 2nd generation primary console and the console was found to pass all manufacturing and qa specifications.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: 10885104
• MDR Text Key: 217688458
• Report Number: 3003306248-2020-00095
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• 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: 5689286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, OUS; CENTRIMAG MOTOR, OUS