MAUDE Adverse Event Report: THORATEC CORPORATION CENTRIMAG MOTOR, OUS; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-10002

Device Problems Mechanical Problem (1384); Material Deformation (2976)

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

Event Date 06/10/2022

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

It was reported that the cable to the centrimag motor was defective.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag motor not functioning properly was confirmed.The centrimag motor (serial number: (b)(6)) was returned for analysis to the european distribution center (edc) and was evaluated and tested on 07sep2022.Functional testing was performed and a break in the cable was found by the while measuring resistance on a1+/- and b1+/1-.A video of the testing was submitted for review which showed the damage to cable near the distal motor bend relief.It was advised that the motor be scrapped.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 quality assurance 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 section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The motor was irreparable due to the defective cable.There were no patient consequences.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag motor not functioning properly was confirmed.The centrimag motor (serial number: (b)(6)) was returned for analysis to the european distribution center (edc) and was evaluated and tested on (b)(6) 2022.Functional testing was performed and a break in the cable was found while measuring the resistance on a1+/- and b1+/-.The motor was forwarded to the product performance engineering (ppe) lab for further analysis.The motor was connected to a test console, monitor and mock loop.Upon powering on the console, a motor disconnected: m2 alarm appeared on the monitor.The resistances of the underlying wires of the motor cable were measured.An open loop was measured on lines a1+/- and b1+/- upon manipulation of the cable near the proximal motor bend relief.The cable was stripped, and kinks were found in several wires near the proximal bend relief.The root cause for reported event was due to conductor breakdown within the motor cable; however, the root cause for the damage was unable to be conclusively determined through this investigation.A capa was implemented to address wire fatigue of the motor cable through a re-design of the motor cable.During the investigation it was determined that the returned motor cable has wire fatigue, and the motor was manufactured prior to the implementation.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 section 12.1 entitled "appendix i primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.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 CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15625151
• MDR Text Key: 306355814
• Report Number: 2916596-2022-14559
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2023

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
• Device Lot Number: 7993588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 10/31/2022; 06/13/2023
• Supplement Dates FDA Received: 11/17/2022; 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2011
• 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