MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS

Model Number 201-90401

Device Problem Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2018

Event Type  malfunction  

Manufacturer Narrative

This medwatch is reporting the primary console.The motor is reported under medwatch mfr report # 2916596-2018-05291.The device is expected to be returned for analysis.It has not yet been received.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.It was reported that the pump suddenly failed during patient use when the speed dropped to 0 rpm.The primary console was switched to the backup primary console successfully.The patient was at rest in the icu during the event.The patient reportedly was not symptomatic or injured due to the event, and is in stable condition.The error was reproduced using a demo set.No additional information was provided.

Manufacturer Narrative

Correction: this event occurred at (b)(6).Manufacturer's investigation conclusions: the reported event of a speed drop to 0 rpm during use was not confirmed.The centrimag 2nd generation primary console was returned for analysis and a log file was submitted for review.A review of the submitted log file showed events spanning approximately 13 minutes ((b)(6) 2018 07:48:00 ¿ (b)(6) 2018 08:01:00 per time stamp).The speed was captured at 0 rpm with a flow of 0 lpm throughout the log file; however, the log file did not capture the reported drop in speed.The motor was disconnected from the console from 07:48:00 ¿ 07:49:00 as indicated by the alarm ¿motor disconnected: m2¿.When the motor was connected to the console, the alarms ¿pump not inserted: m3¿, ¿set pump speed not reached: m5¿, and ¿flow signal interrupted: f2¿ were active throughout the log file, indicating that the pump was not inserted into the motor.The console was powered down at 08:01:00.The returned console was evaluated and tested.The console was found to be very dirty and the air holes were covered with labels.Gum was found on the console¿s housing.The console returned with an expired battery pack and was replaced with a new one.The console was able to power on and pass the self-test as intended.A battery maintenance and a functional and safety test was performed.The console functioned as intended and passed all tests.The reported event was unable to be reproduced during the investigation.Reports of similar events will continue to be tracked and monitored.The root cause for the reported event was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE, OUS
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8139874
• MDR Text Key: 129581940
• Report Number: 2916596-2018-05290
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90401
• Device Catalogue Number: 201-90401
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 55