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

Model Number 201-10002

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

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

Event Date 12/04/2022

Event Type  malfunction  

Manufacturer Narrative

All available information for conducting this investigation was collected and no additional follow-up attempts will be performed.

Event Description

It was reported that there was an s1 alarm during self-test and the motor was exchanged.

Manufacturer Narrative

Section d4: catalog number was inadvertently added in initial report and is not applicable for this device.Manufacturer's investigation conclusion: the reported event of an s1 alarm was confirmed; however, the returned centrimag motor (serial number (b)(6)) was determined to have been unrelated to the cause of the event.The cause of the reported event will be addressed via the centrimag console¿s investigation (serial number (b)(6)).The returned motor was received and functionally tested at the european distribution center.The motor was observed to have a small puncture on its motor cable upon arrival; however, the motor functioned as intended throughout all testing.Due to the motor¿s cable being irreparable, the motor was advised to be scrapped.Per customer request, the motor was scrapped and was returned to the customer site labeled as ¿not for human use.¿ review of the device history record for the centrimag motor, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual (rev.L) section 3 ¿warnings and 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." centrimag motor ifu (rev.F) 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.

• Brand Name: CENTRIMAG MOTOR, OUS
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16279162
• MDR Text Key: 308670648
• Report Number: 2916596-2023-00704
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

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: 201-10002
• Device Catalogue Number: 201-10002
• Device Lot Number: 7493577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2020
• 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