MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, OUS; Pump, blood, cardiopulmonary bypass, non-roller type

Model Number 201-10002

Device Problem Mechanical Problem (1384)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

It was reported that the screw that held the pump was threaded.The locking ring screw was broken and there was a large cut in the motor cable at the side of the connector, which had electric insulation tape.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of damage to the set screw on the centrimag motor was confirmed.The centrimag motor (serial number: (b)(6).Was returned for analysis to the european distribution center (edc) and upon initial observation, the head of the set screw was found broken off.The motor was functionally tested and was able to support a mock loop without any issues or alarms activating; however, during testing the set screw was unable to be closed.The centrimag motor was forwarded to the product performance engineering (ppe) lab.Further testing was performed on the motor within the ppe lab.The returned motor was connected to a mock loop, test monitor, test console, and test flow probe.The set screw was unable to be closed.The system was run for an extended duration, and the cable was manipulated by hand.No issues or alarms activated throughout the duration of testing.The insulation and resistance of the underlying wires of the motor cable were tested and all values were found to be within specification.Multiple good faith efforts were sent asking if the motor was in use at the time of damage and if there were any patient impacts related to the threaded screw.To date, information has been provided.A root cause for the reported event was unable to be conclusively determined through this investigation.The device history records were reviewed for the centrimag motor (serial number: (b)(6) and the motor was found to pass all manufacturing and qa specifications.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 2nd generation centrimag system operating manual table 16 entitled ¿console alarms & alerts¿ addresses how to properly interpret and troubleshoot all system alarms including m5 alarms.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, OUS
• 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: 17905555
• MDR Text Key: 325296812
• Report Number: 3003306248-2023-07164
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2023

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: 201-10002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2008
• 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