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

Model Number 201-10002

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

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2016

Event Type  malfunction  

Manufacturer Narrative

Patient was not involved with this event.The device returned for analysis(if this is true, if not indicate that the device did not return).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

A customer has returned a centrimag motor, because it failed during routine testing.The motor had an intermittent cable fault.The motor worked fine until slight side pressure was applied to the motor bodys cable exit.The motor then instantly stopped and ¿system fault¿ was displayed on the 1st generation console.The same fault occurred, no matter, which console it was connected to.The suspect unit was sent to (b)(4) for evaluation.This event was previously not reported due to no patient being involved with the event.Abbott made the decision on july 13, 2018 to initiate a voluntary recall, therefore this event is being upgraded to reportable.

• Brand Name: CENTRIMAG MOTOR, OUS
• Type of Device: MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 7775146
• MDR Text Key: 117016656
• Report Number: 2916596-2018-03425
• Device Sequence Number: 0
• Product Code: DWA
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 201-10002
• Device Catalogue Number: 201-10002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1