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

Model Number 102956

Device Problems Infusion or Flow Problem (2964); Unexpected Shutdown (4019)

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

Event Date 01/23/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Related mfr # 3003306248-2023-00746.It was reported that the patient's centrimag 2nd generation primary console showed a motor speed drop to 0 rpm and would not go back up.The only alarm that was heard was the low flow alarm.The customer exchanged the patient's centrimag console and centrimag motor for their backup set.

Manufacturer Narrative

Section a: patient information was requested but not provided.Section d6b: explant date was inadvertently added to the initial report but is not applicable for this device.Manufacturer's investigation conclusion: the reported event of the motor speed dropping to 0 rpm and not increasing as well as a low flow alarm was not confirmed.The centrimag motor (serial #: (b)(6) ) was returned for analysis to the service depot.The motor was connected to a test loop and ran for several days with no issues.The motor cable was manipulated, and no issues were noted.The motor was functionally tested and passed all tests.The root cause for the reported event was unable to be conclusively determined through this analysis.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, 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." the 2nd generation centrimag system operating manual, rev.M, section 12.1 ¿appendix i ¿ console alarms and alerts¿ table 16 details how to properly interpret and troubleshoot all system alarms including flow alerts.The device history records were reviewed for the centrimag motor (serial #: (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: 16335206
• MDR Text Key: 309175248
• Report Number: 3003306248-2023-00747
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2010
• 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
• Patient Sex: Male