MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH MAG MONITOR SET; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	201-90404
Medical Device Problem Code	Application Program Version or Upgrade Problem (2881)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: incidental findings: bent pins on pcb.The reported event of the centrimag monitor booting up into loading the management application was confirmed.The returned centrimag monitor (serial number (b)(4)) was evaluated by the service depot alongside known working test centrimag equipment.The monitor¿s left and right connection ports were both tested, and the monitor would always attempt to the load the management application upon being powered on.Any attempt to use the monitor¿s functions would result in the monitor restarting with the same condition.After troubleshooting was performed, it was determined that the monitor¿s firmware had been corrupted.As a result, the monitor¿s main pcb with its cpu had to be replaced with a new component.After this replacement, the monitor booted up as intended.The latest firmware was installed, and a full functional checkout was performed.Atypical events were unable to be reproduced after the replacement of the main pcb.The serviced and repaired monitor was returned to the customer site after passing all tests per procedure.Although the cause of the event was narrowed down to the original pcb with the cpu, further troubleshooting was unable to be performed due to the monitor¿s functions being inaccessible.The latest firmware was unable to be uploaded to the pcb due to the monitor¿s menus being inaccessible.The root cause of the monitor¿s firmware becoming corrupted, resulting in the reported event, was unable to be conclusively determined through this analysis.Review of the device history record for centrimag monitor, serial number (b)(4), showed the device was manufactured in accordance with manufacturing and qa specifications.The mag monitor is an optional accessory for easy handling of the 2nd generation system, however it is not necessary for the system to function.The 2nd generation centrimag system operating manual 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." no further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the centrimag monitor froze in the management loading application screen during mandatory monitor upgrade.The console and monitor were rebooted and unplugged several times with several minutes between powering down and restarting.The monitor remained locked in the same loading screen.

• Brand Name: MAG MONITOR SET
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 12188767
• Report Number: 3003306248-2021-02989
• Device Sequence Number: 3035931
• Product Code: DWA
• UDI-Device Identifier: 07640135140696
• UDI-Public: 07640135140696
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 201-90404
• Device Catalogue Number: 201-90404
• Device Lot Number: 6547420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1