MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

Model Number 201-30300

Device Problem Overheating of Device (1437)

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

Event Date 03/23/2019

Event Type  Injury  

Manufacturer Narrative

This medwatch is reporting the primary console.The motor is reported under medwatch mfr report # 2916596-2019-01483.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was placed on extracorporeal circulatory support.It was reported that the patient was with the device as a left ventricular assist device (lvad) for 4 days before the event.The motor suddenly began to make a noise and heat up, leading to an s3 alarm.The flow probe did not show flow on the screen or on the primary console.The pump was still functioning.The patient was correctly anticoagulated.Inotropes were temporarily used to exchange the primary console.A change to the backup primary console and motor made the noise disappear.The patient was continuously with the lvad for 6 more days when a transplant was performed.No clogs were found in the circuit.No additional information was provided.

Manufacturer Narrative

Section d10, h3, h4: additional information.Manufacturer's investigation conclusions: the reported event of the console going black, blank flow, and a s3 alarm was confirmed.The centrimag console (serial #: (b)(6) was returned for analysis and was evaluated.The console¿s log file was downloaded for review.A review of the downloaded log file showed that on 18apr19 at 22:12, an ifd-shutdown (display dark) occurred, triggering ¿system alert: s3¿ and ¿set pump speed not reached¿ alert.The speed dropped from 3900 rpm (flow of 5 lpm) to a speed of 3200 rpm, with 0 lpm of flow displayed.A further investigation on the returned devices was performed by the r&d department.It was found that there were no faults found with the returned console and it operated as intended.As a result, the reported event could not be correlated to a console related issue.The console was forwarded to the edc.The console was evaluated and tested under work order #67397.The console powered on as intended and no anomalies were found during a functional inspection of the unit.The console¿s battery was replaced, and battery maintenance was started and was completed successfully.A functional test was performed with the returned flow probe (serial #: (b)(6).A safety test was performed.Tests were performed per procedure.The unit was cleaned, and all old labels were removed.The unit was 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: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8512590
• MDR Text Key: 141902695
• Report Number: 2916596-2019-01482
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/14/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention