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

Model Number 102956

Device Problems Loose or Intermittent Connection (1371); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2019

Event Type  Injury  

Manufacturer Narrative

The patient identifier and date of birth were requested but were not provided.The motor is not a single use device.The approximate age of the device is 3 months 25 days.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with extracorporeal circulatory support pump on (b)(6) 2019.It was reported that during the initial device set up and therapy the moment the primary 1st generation console was turned on it starting smoking from under the console fan.The device was switched out to the back up secondary 2nd generation console.When that console was turned on it alarmed "motor disconnect" and would not clear or spin the blood pump.The 2nd generation back up console was turned off and the motor was unplugged.The motor from the primary 1st generation console was connected to the back up secondary 2nd generation console it was powered back up with the new motor.This console and motor configuration started up as expected without any further issue/alarms.It was reported that this put a delay in initiating therapy for the patient.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event was confirmed and reproduced during the evaluation of the returned centrimag primary console associated with this complaint.The returned centrimag motor was evaluated and tested by the service depot under work order #53698569.Continuity testing of the motor's cable revealed a short between analog ground (agnd) and the bearing phase b2 (b2+/b2-) wires.Although the root cause of this damage could not be conclusively determined, it appeared to be a result of wear and tear during repetitive bending or twisting of the cable during use.This damage had the potential to result in the reported event and appears consistent with the damage observed during testing of the related centrimag primary console.The defective motor and console were 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, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA 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: 8479529
• MDR Text Key: 140804875
• Report Number: 2916596-2019-01350
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care 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

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 136