MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30300

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred at (b)(6). No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Related manufacturer reference number: 3003306248-2020-00089. It was reported that the patient was connected to centrimag as a ecmo therapy. Suddenly the screen of the console turned off and the flow probe did not register information about the flow, but the motor was still working. No product will be returned, the patient was still under ecmo therapy at time of reported event. Distributor loaned two other motors. The event resolved with the use of the backup motor and console. The backup motor was used, and changed motors as soon as possible. Additional information received on 08oct2020 stated that the motors were affected by the fsca 2019-08, which states that the customers have experienced unexpected console screen blanking, low flow or no flow, and motor behavior including noise, vibration and heating at a rate of (b)(4). Our investigation has identified certain centrimag motors with serial numbers have an increased susceptibility to electromagnetic interference (emi). The issue can be mitigated through re-calibration of the motor. The centrimag¿ 2nd generation console will be returned.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich 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: 10715938
• MDR Text Key: 214804777
• Report Number: 3003306248-2020-00088
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 201-30300
• Device Lot Number: L06473
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse