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

Model Number 201-90411

Device Problems Overheating of Device (1437); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/18/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the centrimag console had an s3 error with an accompanying burning smell when it was powered on.The console was not in use by a patient at the time of this event.

Manufacturer Narrative

Section d4: expiration date was inadvertently included in the initial report and is not applicable to this device manufacturer's investigation conclusion: the reported event of an s3 alarm was confirmed; however, the reported alarm of the console emitting an unusual smell was not confirmed.A log file was extracted from the returned centrimag console (serial number (b)(6)) upon its arrival at the service depot.The console was stated to have not been in patient use within the timeframe of the reported event (apr2022).An s3: system fault alarm was observed on (b)(6) 2022 at 20:41 during a time that appeared to have been when the console was being set up to be tested.The alarm correlated to a ¿can bus send error¿ sub-fault, and the alarm was muted within the same minute; however, the alarm was not observed to have cleared.Due to this sub-fault, the console¿s flow readings were listed as 0 lpm even after the console and motor were operating at ~1800-2200 rpm from 20:41 ¿ 20:45 on the same day.The system was observed to have been shut down at 20:46.No other notable events were observed.The returned centrimag console was functionally tested at the service depot and was found to perform as intended throughout an extended period; atypical events were unable to be reproduced.The console was opened and its inner pcbs and cables were inspected and appeared unremarkable.The serviced and tested console was returned to the customer site after passing all tests per procedure.The root causes of the reported events were unable to be conclusively determined through this analysis.Review of the device history record for l05451-0005 showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual (rev.M) section 4 ¿warnings and 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.".The 2nd generation centrimag system operating manual rev.M, ¿table 15: console maintenance schedule¿) instructs users to have the centrimag console¿s internal battery replaced every two years.Users are instructed to contact abbott for assistance in replacing the battery, as users may not replace the internal battery without proper training or assistance.The 2nd generation centrimag system operating manual (rev.M) section 12.1-"appendix i - primary console alarms and alerts" contains a list of console alarms and alerts, including s3 alarms, 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
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14287083
• MDR Text Key: 290764578
• Report Number: 2916596-2022-10566
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6141145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1