MAUDE Adverse Event Report: THORATEC CORPORATION CENTRIMAG MOTOR, OUS

Catalog Number 201-10002

Device Problems Mechanical Problem (1384); Nonstandard Device (1420)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2014

Event Type  malfunction  

Manufacturer Narrative

The device returned for analysis.The complaint investigation determined the reported difficulty was the result of a design related wear issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.

Event Description

It was reported that the centrimag motor was not detected by the console.The event occurred during system preparation.During the event, no patient were connected to the system.The customer tested the motor on other systems.The system error presented again.The suspect motor was returned for analysis.This event was previously not reported due to patient involvement.Abbott made the decision on july 13, 2018 to initiate a voluntary recall, therefore this event is being upgraded to reportable.

Manufacturer Narrative

Correction: section g1, g2 and d3.

• Brand Name: CENTRIMAG MOTOR, OUS
• Type of Device: MOTOR
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasonton; pleasanton CA 95488
• MDR Report Key: 7775461
• MDR Text Key: 117017833
• Report Number: 2916596-2018-03338
• Device Sequence Number: 0
• Product Code: DWA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/06/2020
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 201-10002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/22/2018
• Initial Date FDA Received: 08/11/2018
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0103-2019
• Patient Sequence Number: 1