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

Model Number L102956

Device Problem Pumping Stopped (1503)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device ¿ the centrimag primary console is not a single use device.The approximate age of the device will be provided in the supplemental report when the manufacturer's investigation is complete.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was being supported by an extracorporeal circulatory support pump or acute biventricular extracorporeal circulatory support.It was reported that the device alarmed ¿motor not connected¿, and the pump had stopped.Once the pump stopped, the patient¿s status started to decline.The vad coordinator checked the connection from the motor to the pump, and it was all intact.They then disconnected & reconnected the motor cable from the console, and no changes were noticed.The vad coordinator changed consoles and was able to get a flow reading, and turn up the rpms.The patient¿s pump was stopped for about 30 seconds for the initial issue, and then probably an additional 15 seconds several minutes later when we switched out the motor.There was no visual damage noticed on the console.No additional information was reported.

Manufacturer Narrative

Patient information was requested multiple times, however none was provided.Approximate age of device -- 8 years, 11 months.Manufacturer's investigation conclusion: the returned centrimag motor (serial number (b)(6)) was evaluated and tested by the service depot.The reported issue was not reproduced.However, insulation testing of the motor's cable revealed an unintended short in multiple lines.This damage has the potential to result in the reported event.Although the root cause of the damage could not be conclusively determined, it appeared to be a result of repetitive bending or twisting of the cable during use.It was noted that at the time of the reported event the age of the motor was almost 9 years.The defective motor was scrapped.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR
• 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: 8330000
• MDR Text Key: 135854089
• Report Number: 2916596-2019-00665
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2021

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: L102956
• Device Catalogue Number: L102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 06/20/2019; 06/09/2021
• Supplement Dates FDA Received: 06/25/2019; 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1