MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, OUS; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-10002

Device Problems Material Deformation (2976); Insufficient Information (3190); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2022

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 the centrimag motor failed while transferring the motor from the retrieval trolley to the patient's bed after extracorporeal membrane oxygenation (ecmo) retrieval.All connections were secure, and the electrical connection between the motor and console was lost due to potentially damaged motor cable.The motor was exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag motor stopping was confirmed via analysis of the returned centrimag motor (serial number: (b)(6), as the reported event was reproduced during testing.The returned centrimag motor was evaluated at the european distribution center.During functional testing, the motor cable was manipulated by hand which resulted in an m2 and s3 alarm, reproducing the reported event.The unit was forwarded to product performance engineering (ppe) for further analysis.The returned centrimag motor was tested alongside known working test centrimag equipment for additional testing.The motor operated at a set speed of 3000 revolutions per minute (rpm) and a flow of 6.19 liters per minute (lpm) without any issues; however, upon manipulating the motor cable near the bend relief on the housing side, the motor speed dropped to 0 rpm and the flow dropped to 0 lpm, and m2 and s3 alarms activated.Evaluation of the motor cable revealed that several wires had slightly increased resistances.A section of the outer jacket and shielding near the bend relief on the housing side of the cable was then removed to further inspect the underlying wires, revealing that all wires were kinked.The raised resistance and damage to the underlying wires would result in the reported event.A log file was downloaded from the returned centrimag console.On the reported event date of 27aug2022, the system was observed to be operating at the set speed of approximately 2900 rpm with a flow of approximately 3.0 lpm.On (b)(6) 2022 at 08:37, m2: motor disconnected and s3: system alert alarms activated correlating to pump and power related sub faults respectively, and the speed dropped to 0 rpm.The flow reading was also observed to be 0 lpm during these events.The alerts were muted within approximately 1 minute of activation.The system was observed to have been fully shut down on (b)(6) 2022 at 08:41.No other notable alarms were observed in the log file.The reported event was determined to be due to damage to the wires in the centrimag motor cable; the root cause of the damage could not be conclusively determined through this analysis but is consistent with repetitive flexing of the cable over time.The device history records were reviewed, and the records revealed that the centrimag motor, serial number: (b)(6), was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual section 8 ¿emergencies/troubleshooting¿ provides instructions for operation when there is a need to exchange the main console or motor with a backup console or motor.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 10.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), including motor and system alarms, and alarms related to the system stopping, and the appropriate actions to take if the issue does not resolve.Centrimag motor instructions for use instructs the user to inspect the centrimag motor, cable, console connector, and locking mechanism for any damage prior to use.If any component is damaged, do not use the centrimag motor.This document states that if the unit fails to operate according to the motor specifications or a console diagnostic error indicates a centrimag motor malfunction, it should be returned.Additionally, this document instructs the user to always have a spare centrimag motor and back-up equipment available.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Damage on the motor cable was confirmed.The motor was able to run, but when the motor cable was moved at the point of entry into the motor housing, the motor stopped, and the console reported an m2 alarm.The motor and console was exchanged, and the problem resolved following the motor exchange.Related manufacturer reference number: 3003306248-2022-12505 (console).

• Brand Name: CENTRIMAG MOTOR, OUS
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15365636
• MDR Text Key: 305807037
• Report Number: 3003306248-2022-12504
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-10002
• Device Lot Number: 8263960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1