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

Model Number 201-10002

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

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 during the boot up of the centrimag device, the console turned on and at the end of the self-test, there was an m2 error which was for a motor disconnected alarm.The console was not in use with the patient.The device continued to emit an m2 alarm.The motor was taken out of service and returned.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a motor disconnected: m2 alarm was confirmed.The centrimag motor (serial #: (b)(6) ) was returned for analysis and was connected to a test console and flow probe and upon startup, a motor disconnected: m2 alarm activated, confirming the reported event.The motor cable was inspected, and during inspection the motor cable was manipulated.When manipulated near the motor end bend relief, the pump would move slightly.The motor was scrapped and forwarded to product performance engineering (ppe) for further analysis.Upon further analysis, when connected to a mock loop, the motor would immediately alarm for motor disconnected: m2.When the motor cable was manipulated, the pump was seen to move slightly as if it was trying to center itself.A motor alarm: m4 also activated and was not able to clear.The motor cable underwent a resistance test and increased resistance was observed.Upon manipulation of the cable, open leads were found across the drive and bearing phases lines of the motor.The root cause for the reported event was conclusively determined to be due to wire fatigue in the motor cable.The device history records were reviewed for the centrimag motor (serial #: (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.

• 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
• MDR Report Key: 11180746
• MDR Text Key: 240404884
• Report Number: 3003306248-2021-00003
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

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: 03/25/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1