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

Model Number 201-30300

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2022

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 the centrimag primary console was cleaned after use and when the power cable was inserted back into the console socket, it smelled of burnt plastic and fire at the socket location.The unit was removed from use.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental finding: severed ac power cord.The reported event of the returned centrimag console (serial number (b)(6) having scorch marks was confirmed, as this damage and deformation was observed near the console¿s ac power cord socket upon arrival.The console¿s ac power cord was also observed to have been deformed on its connector end with one of the console¿s metal prongs stuck inside of it.Due to the observed damages, the console was unable to be functionally tested, as power was unable to be applied to the console.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for the centrimag console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual (¿powering up the console¿) instructs users how to properly set up and connect the centrimag console to power using the appropriate outlets.The 2nd generation centrimag system operating manual (¿maintenance following each patient use¿) instructs users on how to properly clean the centrimag console after each use, and to avoid spraying fluids directly into the console.The 2nd generation centrimag system operating manual also instructs users to always keep the centrimag console in an environment where air can flow freely.If the console¿s fan is blocked in some way, the console may overheat.No further information was provided.The manufacturer is closing the file on this event.

• 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: 13580592
• MDR Text Key: 290543010
• Report Number: 3003306248-2022-00025
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Lot Number: L06775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1