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 10/16/2023

Event Type  malfunction  

Event Description

Related mfr # 3003306248-2023-07176.It was reported that a centrimag system did not work properly.The primary console, centrimag motor, and the mag monitor required service.According to the hospital staff, the monitor did not work.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

A1-a4 - there was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.Manufacturer's investigation conclusion: the centrimag motor (s/n: (b)(6) ) was evaluated following the reported event of the centrimag monitor not working.A log file was extracted from the console and did not show any atypical events indicating an issue with the motor.The returned centrimag motor was functionally tested and operated as intended.The motor¿s cable was flexed throughout its entire length and no alarms were observed.The motor was returned to the customer site after passing all tests per procedure.The reported event was unable to be correlated to an issue with the centrimag motor.The 2nd generation centrimag system operating manual, rev.M, section 4 entitled "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." the 2nd generation centrimag system operating manual, rev.M, table 16 entitled ¿console alarms & alerts¿ addresses how to interpret and troubleshoot all system alarms including motor and flow alarms.The device history records were reviewed for the centrimag motor (s/n: (b)(6)) and the motor was found to pass all 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: 18096772
• MDR Text Key: 328072329
• Report Number: 3003306248-2023-07175
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• 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
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2018
• 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