MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, CAN

Model Number 100170420

Device Problems Communication or Transmission Problem (2896); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2019

Event Type  Injury  

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 during testing of the primary console a power on test fail alarm occurred.The account rebooted the system but the alarm kept occurring.The account left the system alone for awhile, when they booted up the system a second time a motor disconnected alarm occurred.The account switched to the backup system, however, the alarm still occurred.No further information was provided.

Manufacturer Narrative

Manufacturer investigation conclusion: the reported event of a power on test failed alarm was not confirmed.The motor was evaluated and tested.The reported event was unable to be duplicated or verified.The motor was run with the returned and associated console (serial #: (b)(6) and flow probe (serial #: (b)(6).The motor functioned as intended and no alarms were observed at any point.A full functional checkout was performed, and the unit passed all tests.The motor cable was inspected, and no issues were found.The motor was returned to the customer site.The root cause for the reported power on test failed alarm was not 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." 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." 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 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.No further information was provided.The manufacturer is closing the event on the file.

• Brand Name: CENTRIMAG MOTOR, CAN
• Type of Device: MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9469144
• MDR Text Key: 174510504
• Report Number: 2916596-2019-05746
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100170420
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/13/2019
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention