MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problem Insufficient Information (3190)

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

Event Date 01/31/2023

Event Type  malfunction  

Event Description

Related mfr #: 2916596-2023-00745.It was reported that the console and motor were displaying an s3 alert, motor not connected.

Manufacturer Narrative

Current reported information indicates that there is no patient involvement; therefore, patient information is not pertinent to the investigation.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacture¿s investigation conclusion: the reported event of the console and motor displaying s3 alarms and m2 motor not connected alarms was confirmed via visual analysis and testing of the unit as well as visual analysis of the downloaded log file from the returned unit.The centrimag motor (serial number (b)(6)) was returned and evaluated at the service depot on (b)(6) 2023.During the evaluation, the centrimag motor and centrimag console (serial number (b)(6)) were connected to a mock test loop and a log file was downloaded.The downloaded log file contained events spanning approximately 16 days ((b)(6) 2022 - (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2023, (b)(6) 2023, (b)(6) 2023, (b)(6) 2023 per the timestamp).The log file captured intermittent m2 motor disconnected alarms active between the events of (b)(6) 2022 at 17:03:30 and (b)(6) 2023 at 11:36:15; however, the events prior to (b)(6) 2022 are associated with data associated with the manufacture of the motor.The alarms after (b)(6) 2022 appear to clear and resolve on their own intermittently; however, they would reappear sporadically throughout the log file.Throughout the log file, it appears as if the system was shut down several times in an attempt to resolve the reported event on (b)(6) 2023.During operation, the motor¿s cable was flexed near its connector bend relief and immediately, the console began alarming with an s3 and m2 alarm, confirming the reported event.The s3 alarms that were reproduced during testing were not observed in the log file.The returned motor and console were then separated and connected to their own independent test loops.During operation of the motor, m2 and s3 alarms were immediately active when the motor cable was flexed, confirming that the motor was at fault.When the console was tested independently, it was able to operate as intended with no alarms observed during operation.The motor was deemed not functional and cannot be certified for use.The motor will be removed from service; however, the customer requested that the motor be returned to the site for educational purposes.Provided information stated that stated there was no patient connected to the system at the time of the reported event.Based on the testing of the returned motor, wire fatigue in the motor cable is the likely root cause.Further testing could not be performed due to the customer requesting the return of the motor.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.The 2nd generation centrimag system operating manual section 3 "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 section 11.1 entitled "appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including m2, s3, and other motor-related alarms, as well as appropriate operator response to these events.Review of the device history record for the centrimag motor, serial number (b)(6), showed the motor was manufactured in accordance with manufacturing and qa specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 16293917
• MDR Text Key: 308754404
• Report Number: 3003306248-2023-00579
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 7640135140078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1