MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE

Model Number 102954

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.Approximate age of device - the console is not a single use device.The approximate age of the device is 0 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 report of a console smoking when being powered on was confirmed and reproduced during testing of the returned centrimag primary console.The returned centrimag primary console was evaluated and tested by the service depot under work order #(b)(4).Due to the reported event of smoke when powering up the unit, the console was not plugged into ac power.An internal inspection of the console was conducted, revealing a cracked and burnt power semiconductor component (power switch) on the motor control (lmcebp) printed circuit board (pcb), confirming the reported event.Due to no more 1st gen primary console parts being available, the unit could not be repaired.The customer was notified that the unit will be scrapped.The associated flow probe was tested with a lab owned console and was found to be intermittent.As a result, the flow probe was scrapped.Applicable sections of the centrimag primary console service process were performed.However, due to the damaged console component a full functional test could not be performed.The root cause of the burn component was determined to be a defective centrimag motor returned with this complaint and which was used during the event.The flow probe being defective could not be correlated to the reported event and was noted to be an additional observation.All defective devices 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 1ST GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• 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: 8479521
• MDR Text Key: 140803876
• Report Number: 2916596-2019-01349
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 7640135140672
• UDI-Public: (01)7640135140672
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 102954
• 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: 08/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 136