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

Model Number 201-90411

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2019

Event Type  Injury  

Manufacturer Narrative

This report addresses the console.The motor is reported under mfr.#2916596-2020-00795.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that while the patient was on extracorporeal membrane oxygenation (ecmo) support, the motor became noisy and very warm, and a burning smell was noted.As the healthcare provider was powering up the backup console, the console in use went blank (no lights or power) and the motor stopped.The motor was exchanged.Ecmo support was discontinued on (b)(6) 2019.The event was reported to have been resolved.

Manufacturer Narrative

Manufacturer's investigation conclusions: the reported event of the console going blank was confirmed via the log file; however, the reported event of the motor stopping was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned to analysis and a log file was downloaded from the console for review showing events spanning approximately 133 days ( 15nov2019 ¿ 27mar2020 per time stamp).The console was operating a motor at speed of ~4400 rpm with a flow of ~3.7 lpm.On (b)(6) 2019 at 03:29:00, the sub fault ifd_shutdown_detected activated and triggered a ¿system alert: s3¿ and ¿set pump speed not reached: m5¿ activated.The motor speed dropped to ~3300 rpm and the flow dropped to 0 lpm.The motor speed recovered, and the pump was removed from the motor at 03:30:00.The console was evaluated and tested.The console powered on as intended and passed the self-test.The console was functionally tested and performed as intended.Preventative maintenance was performed, and the console can be returned to the customer.Reports of similar events have been documented and corrective action had been initiated to investigate the issue further.The investigation has determined that the issue is not related to a 2nd generation primary console related issue.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 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
• MDR Report Key: 9703505
• MDR Text Key: 181786538
• Report Number: 2916596-2020-00796
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

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: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 05/28/2020
• Supplement Dates FDA Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1