MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH; MOTOR

Catalog Number 201-10002

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

Patient Problem No Patient Involvement (2645)

Event Date 10/06/2017

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 a centrimag pump had pump stoppages.The console displayed "motor disconnected" alarm.When manipulating the cable, the alarm would sound.Not patient was involved with this issue.This event was previously not reported due to no patient involvement.Abbott made the decision on july 13, 2018 to initiate a voluntary recall, therefore this event is being upgraded to reportable.

• Type of Device: MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7775338
• MDR Text Key: 117019622
• Report Number: 2916596-2018-03381
• 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: 04/02/2020
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 08/11/2018
• Supplement Dates Manufacturer Received: 03/18/2020
• Supplement Dates FDA Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0103-2019
• Patient Sequence Number: 1