MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE

Model Number 102954

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

Information was not provided.The primary console is not a single use device.The approximate age of the device from the date of manufacture is 7 years, 2 months.The device was returned for analysis.Evaluation is not complete.No additional information was provided.A supplemental report will be submitted when the device analysis is completed.

Event Description

The patient was implanted with an extracorporeal circulatory support device.It was reported that a self-test failure message on the console occurred during transport of a patient to another institution.This did not occur when the console was powered on.The perfusionist was able to transfer to the backup console and motor in a safe manner.There was no patient harm.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of a centrimag failure upon startup could not be confirmed nor reproduced during the investigation.The returned centrimag primary console was evaluated and tested by the service depot under work order #(b)(4).The reported issue could not be duplicated.The unit powered up normally and operated a test pump and motor on a mock circulatory loop without any issues.Inspection of the unit did not identify any issues.A battery maintenance required message activated on the display.The required battery maintenance was performed without any issues.The unit was functionally tested per the centrimag primary console service process (doc.#(b)(4)) and the unit passed all tests.A new backup system warning label was applied per field action fa-q318-mcs-1.The tested and serviced unit was returned to the customer site along with its associated power cord.Reports of similar events will continue to be tracked and monitored.The centrimag primary console operating manual (doc.#(b)(4)) describes all alarms and alerts, including the battery maintenance required alert.If the battery maintenance required alert occurs, the operating manual states "do not use the console.Perform battery maintenance according to the instructions described in the battery maintenance procedure ((b)(4))." this document also states that battery maintenance should be performed every 6 months.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 1ST GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7932576
• MDR Text Key: 122650240
• Report Number: 2916596-2018-04360
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102954
• Device Catalogue Number: 102954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2019
• Patient Sequence Number: 1