MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30300

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2020

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 reference number: 3003306248-2020-00055.It was reported that there was a centrimag motor failure.

Event Description

Additional information: no alarms associated with the motor failure were reported.The system was in use on a patient when the alarm was observed.Both the console and motor were exchanged.The patient did not experience any adverse consequences.

Manufacturer Narrative

Section b5, d10, h3, and h4: additional info.Section d4 (udi): correction.Manufacturer's investigation conclusion: the reported event of a motor failure was confirmed; however, it was revealed that the centrimag console was unrelated to the cause of the event.The returned centrimag console was functionally tested and was found to perform as intended.The serviced and tested console was returned to the customer site after passing all tests per procedure.Review of the device history record for centrimag console s/n (b)(6) showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual section 4"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"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." centrimag motor ifu 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.The 2nd generation centrimag system operating manual section 12.1"appendix i - primary console alarms and alerts" contains a list of console alarms and alerts, including motor and s3 alarms, as well as appropriate operator response to these events.It was revealed that the root cause of the reported event was related to the returned centrimag motor.No further information was provided.The manufacturer is closing the file on this event.

• 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: 10181407
• MDR Text Key: 196947541
• Report Number: 3003306248-2020-00054
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, OUS.