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

Model Number 201-30300

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer investigation conclusion: no further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported during electrical testing, the customer observed a "power leakage problem".No patient was involved with the event.The console will reportedly be returned for evaluation.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a power leakage problem was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis and was evaluated and tested.The system was able to be powered on as intended and passed the self-test.The log file was downloaded from the returned console for review and no anomalies were found.The system functioned as intended.The reported power leakage problem was investigated; however, no anomalies were found.The battery pack was replaced, and battery maintenance was successfully performed.Preventative maintenance and a safety test were performed procedure, and no anomalies were found.The console was returned to the customer.The root cause for the reported power leakage was not conclusively determined through this analysis.Per additional information, the console functioned as intended but wanted it checked as a precaution.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: 9475025
• MDR Text Key: 172559410
• Report Number: 2916596-2019-05777
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2020

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: 01/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 02/10/2020; 03/04/2020
• Supplement Dates FDA Received: 02/21/2020; 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1