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 Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2019

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 when the account attempted to transfer the patient from the bed onto the transport trolley an s3 system error alarmed and the flow reading was lost from the display.The account stated that the pump revs were still displayed and the tubing was felt to ensure flow was maintained, which it was.The backup console was powered up, and the flow probe and remainder of the circuit were attached; flow reading returned and the patient was transferred without further incident.No further information was provided.

Manufacturer Narrative

Manufacturer investigation conclusion: the reported event of a s3 alarm and blank flow was confirmed via the downloaded log file.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned to the edc belgium for analysis and was evaluated.A log file was downloaded from the console for review.A review of the downloaded log file showed that on (b)(6) 2019 at 10:23, the motor speed was 3899 rpm but the displayed flow was 0 lpm due to a sub fault ¿can bus send error¿.A ¿system alert: s3¿ alarm activated.The system was rebooted, and the error resolved.The console was visually inspected, and no anomalies were found.The system functioned as intended and the reported event was unable to be reproduced.A new battery was installed in the console.Battery maintenance and safety test were completed per procedure.The root cause for the reported event was not conclusively determined through this analysis.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 CA CH-80 05; SZ CH-8005
• MDR Report Key: 9261919
• MDR Text Key: 164594894
• Report Number: 2916596-2019-05136
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

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: 201-30300
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1