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

Model Number 102956

Device Problems Break (1069); Mechanical Problem (1384)

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

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the motor locking feature had a broken screw.There was no patient involved and no alarms for the event.

Manufacturer Narrative

Manufacturer's investigation findings: the reported event of a damaged screw on the motor locking ring was confirmed.The centrimag motor (serial #: (b)(6)) was returned for analysis to the service depot and was evaluated and tested.The reported event of a damaged screw was confirmed.The locking ring screw was unable to rotate.The locking ring was replaced with a new one and the motor was functionally tested.The motor operated as intended.A full functional checkout was performed, and the unit passed all tests.The replaced locking ring was forwarded to product performance engineering (ppe) for analysis.Upon further analysis with ppe, the damaged to the set screw on the locking ring was confirmed.The screw was unable to completely turn and was stuck in the ring.No further testing was performed.The root cause for the reported event was unable to be conclusively determined through this analysis.The 2nd generation centrimag system operating manual 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 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 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: 12788789
• MDR Text Key: 281920547
• Report Number: 3003306248-2021-05702
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

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
• Device Operator: Health Professional
• Device Model Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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