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

Model Number 201-90411

Device Problems Loss of Power (1475); Pumping Stopped (1503); Unexpected Shutdown (4019)

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

Event Date 06/16/2019

Event Type  Injury  

Manufacturer Narrative

The motor is being reported under mfr # 2916596-2019-03004.Additional information was request, however was not provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was supported by an extracorporeal circulatory support device.It was reported that the console powered down without any alarms.The circulatory support was switched from a centrimag pump to a maquet rotoflow pump.The patient was on day 6 for vv cps support.The patient did not received heparin for 5 days.Additional information was request, however was not provided.

Manufacturer Narrative

Section: h6 correction section h4: additional information manufacturer¿s investigation conclusion: the report of an unexpected console shutdown was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console serial number (b)(6).Per the log file, on the reported event date of (b)(6) 2019 the console was supporting a system at a speed of approximately 2900rpm and a flow of approximately 4.1lpm for over 27 hours.At approximately 8:44pm on (b)(6) 2019 the log file captured a system shutdown event, consistent with reported information.The root cause of this event could not be conclusively determined from the log file.The returned centrimag 2nd gen primary console was evaluated and tested by the service depot.The reported complaint could not be reproduced during their evaluation.The console was tested along with its associated motor and flow probe.The console did not shut off at any point nor did it alarm with any alerts during the evaluation.Full functional checkout was performed per the centrimag 2nd gen primary console service process and the unit passed all tests.A successful routine battery maintenance was performed to the console's battery.The returned console was found to function as intended.As a result, the root cause of the reported event could not be conclusively determined nor correlated to a console related issue.The tested and serviced console was returned to the customer site.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.

Manufacturer Narrative

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: 8747816
• MDR Text Key: 149624043
• Report Number: 2916596-2019-02932
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2020

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 Expiration Date: 01/31/2021
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6835921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 08/13/2019; 02/10/2020
• Supplement Dates FDA Received: 08/26/2019; 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR