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

Model Number 201-90411

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

The device was received but has not been evaluated yet.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the centrimag (cmag) console alarmed s3 alert while in used on a patient.After pressing the alarm acknowledge button, the alarm continued to reoccur, more than 4-5 times.Patient remained stable with the cmag speed 4200 rpm and no change in flow from the patient's baseline.The patient has been on support for approximately 1 week.The patient equipment was changed to the backup motor and console.No further information provided.

Manufacturer Narrative

Section a2-a4, h4: additional information manufacturer's investigation conclusion: the reported event of a s3 alarm was confirmed via the log file.The centrimag 2nd generation console was returned to mcs zurich for analysis and was evaluated.A log file was downloaded from the console for review.The console was operating a motor at 4200 rpm with a flow of 3.7 lpm.Operation continued as intended with a flow ranging between 3.7 lpm ¿ 3.9 lpm.On (b)(6) 2018 at 05:50, the sub fault, ¿sf_sps_fan_speed¿ occurred and triggered the ¿system alert: s3¿.The alert was able to be muted and cleared, but reoccurred multiple times.The system continued to support the operating speed of 4200 rpm with a flow of 3.9 lpm.At 06:13, the user set the pump speed to 0 rpm and the pump was removed.The returned console was further investigated, and the fault could not be reproduced.The console and the returned and associated flow probe were connected to a test loop and test motor and operated as intended as together.No fault occurred when the console was operating on mains power supply or battery power.The system was able to operate for one day at 4200 rpm with a flow of 3.8 lpm.The console¿s housing was opened for an internal inspection and dust and dirt was found inside of the returned console.The console¿s fan was removed, and viscous dirt was found at the rear panel of the console where the fan was mounted.The fan was covered in dust and dirt.The fan ran at its intended frequency throughout the investigation.It was determined that the reported fan issue was caused by the dust and dirt blocking the fan temporarily or that conductive dirt particles causing the fan not to operate at its designed frequency.The console¿s interior was cleaned thoroughly, and the dirty and suspect fan pre-assembly was replaced with a new one.The console¿s battery pack and pouch were also replaced with new ones.The repaired console was subjected to the repair and maintenance procedure and passed all.During reprocessing, the console¿s software was updated to the current revision.The repaired and tested console was forwarded to mcs burlington for the final steps of reprocessing.The root cause of the reported event was determined to be due to the dust and dirt inside of the console.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual 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 entitled "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." 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 CA CH-80 05; SZ CH-8005
• MDR Report Key: 7942450
• MDR Text Key: 124138825
• Report Number: 2916596-2018-04290
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• 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: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 69