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

Model Number 102956

Device Problem Visual Prompts will not Clear (2281)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

Information was not provided.The motor is a single use device.The device has been returned but has not yet been investigated.No further information is available at this time.A supplemental report will be submitted with the manufacture investigation is completed.

Event Description

It was reported that the primary console indicated a system alert (s3) alarm.The primary console and motor were removed from service for return to the manufacturer for evaluation/repair.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: this per was determined to be a duplicate to (b)(4).The returned centrimag motor was evaluated and tested under that complaint.The returned centrimag motor (serial number (b)(4).Was evaluated and tested by tech service under work order # (b)(4).The reported issue could not be duplicated during testing.The motor cable was inspected and no issues were observed.The motor was tested with the 2nd gen primary console associated with the complaint (serial number (b)(4).The motor did not give any error messages and no alarms were observed.The test ran successfully with the correct flow and speeds at all times.A full functional checkout was performed per the centrimag motor service process and the motor passed all tests, functioning as designed during testing.The tested motor was returned to the customer site.The reported event was confirmed during the analysis of a data log file retrieved from related 2nd gen primary console (serial number (b)(4), evaluated under (b)(4).No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8093030
• MDR Text Key: 128066242
• Report Number: 2916596-2018-05007
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

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: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 11/20/2018
• Supplement Dates Manufacturer Received: 04/12/2019
• Supplement Dates FDA Received: 04/22/2019
• Patient Sequence Number: 1