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); Infusion or Flow Problem (2964)

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

Event Date 10/01/2020

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: 3003306248-2020-05462.It was reported that the centrimag unit pump stopped and operator did not see any blood flow for 5 seconds.Rotations per minute, and flow were at zero.The pump restarted after 5 seconds of stopping.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the motor speed and flow dropping to zero 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 with events occurring on (b)(6)2020 took place at abbott during lab testing.The console was operating a motor at a speed of ~4500 rpm with a flow of ~3.5 lpm and on (b)(6) 2020 at 15:36:17, a flow below minimum: f3 alarm activated and the flow and motor speed dropped to 0.A set pump speed not reached: m5 alarm then activated at 15:36:23.These alarms were able to be muted and cleared by 15:36:28.The expected motor speed and flow values resumed at 15:36:30.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was evaluated and tested, and the reported event was unable to be reproduced.The console was tested with the returned an associated motor and flow probe for an extended period of time, including overnight, and was always able to keep at the set rpm speeds and lpm levels with no loss of flow.No alarms activated during testing and the console always performed as intended.A full functional checkout was performed, and the unit passed all tests.The unit was returned to the customer site.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 qa specification.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.

Event Description

It was reported that the patient did not have an adverse event associated with the failure, the perfusionist switched out the console and drive.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• 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: 10895414
• MDR Text Key: 221291100
• Report Number: 3003306248-2020-05461
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 7483729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR
• Patient Age: 42 YR
• Patient Weight: 91