MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

Model Number 201-30300

Device Problems Pumping Stopped (1503); Power Problem (3010)

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

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

The event occurred at (b)(6). No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was placed on extracorporeal circulatory support on (b)(6) 2018. It was reported that the primary console alarmed with error code b1 while in use supporting a patient. The primary console was switched to the backup system. The pump worked normally with the replaced primary console. The patient was not harmed or injured due to the event. No additional information was provided.

Manufacturer Narrative

Manufactures investigation conclusion: the centrimag primary console was not returned for analysis and no log files were submitted for the event. As a result, the reported event could not be confirmed and a root cause could not be conclusively determined. However, per reported information, an engineer on site performed battery maintenance and the unit passed. The engineer also operated the console and battery with a test loop and both devices worked without any issues. Since the system operated as intended, the customer was informed that they did not have to return the unit. Reports of similar events will continue to be tracked and monitored. The 2nd generation centrimag system operating manual (doc. #pl-0280, rev. 05) section 7. 3-"recommended preventative maintenance" contains table 16, which states that battery maintenance should be performed every 6 months and that the internal battery (internal rechargeable battery pack) should be replaced every 2 years. A review of the device history records revealed the device met applicable specifications. No further information was provided. The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND 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: 7697025
• MDR Text Key: 114555565
• Report Number: 2916596-2018-02656
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 201-30300
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 07/17/2018 Patient Sequence Number: 1