MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number L201-90411

Device Problem Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2019

Event Type  Injury  

Manufacturer Narrative

Patient information not provided.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that a battery failure alarm were observed on (b)(6) 2019.At that time there was nothing in the room that could have bumped and caused the issue.Everything was plugged into red outlets and both consoles were showing that they were properly connected to the wall.Once a quick assessment of the patient, pump, and console was completed, they placed the patient on the backup console and pulled the console.Additional information was requested but not yet provided.

Event Description

Centrimag motor is in manufacturer report number #2916596-2019-05566.

Manufacturer Narrative

Additional information: b5; d10; d11; h3; h4.Manufacturer's investigation conclusion: the report of a battery module fail:b1 alert was confirmed through the analysis of a data log file retrieved from the returned centrimag 2ng gen primary console ((b)(6)).Per the log file, on (b)(6) 2019 the console was supporting a system for over 745 hours without any issues.However, at ~7:39am on (b)(6) 2019 the console alarmed with a battery module fail:b1 alarm as a result of the internal battery being briefly captured as disconnected and activating a sf_sps_battery_modul_fail sub-fault.This condition resolved itself within 26 seconds of activating and did not re-occur throughout the remainder of the log file.During this event the console continued to support the system at the set speed.The returned centrimag 2ng gen primary console and its associated flow probe were evaluated and tested by the service depot.The reported complaint was verified during their evaluation.The console alarmed with a b1 alarm upon startup.However, further inspection revealed that the console's internal battery connector was unplugged.The root cause of the battery not being connected could not be conclusively determined during the investigation, nor could the exact time that it was disconnected.However, an improperly connected internal battery could result in the reported events.The connector was plugged back in and battery maintenance was performed successfully.No further alarms were observed after powering up the console.The console was operated with a test system and its associated flow probe ((b)(6)) for an extended period of time and the system always operated as intended.Full functional checkout was performed per the centrimag 2nd gen primary console service process and the unit passed all tests.Once the console's internal battery was properly connected the returned console and its battery were found to function as intended.The tested and serviced console was returned to the rental pool.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual (us) section 9.3-"recommended preventative maintenance" states "the user may not replace the internal battery without proper training by thoratec or its distributor.Please request assistance by calling thoratec customer service if the internal battery requires replacement." section 9.4-"battery maintenance procedure" outlines the battery maintenance procedure and indicates that the battery maintenance procedure should be performed every 6 months.This section also warns that if the system displays the message battery charger fail or battery module fail after battery maintenance is performed, then do not use the system.Section 4-"warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." section 10-"emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console, and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.Section 12.1-"appendix i - primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9427801
• MDR Text Key: 169859174
• Report Number: 2916596-2019-05567
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: L201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6897836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR
• Patient Outcome(s): Hospitalization; Required Intervention