MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

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 console is being reported under mfr # 2916596-2019-02932.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

Manufacturer¿s investigation conclusion: the report of an unexpected console shutdown could not be confirmed nor reproduced during testing of the returned centrimag motor.The returned motor was evaluated and tested by the service depot.The reported complaint could not be duplicated during their testing.The motor was tested along with its associated console, flow probe and mag monitor.The console and monitor did not shut off at any point and the displays of each device showed all functions while running the motor.No alarms or any other issues with displayed parameters were observed.Full functional checkout was performed per the centrimag motor service process and the unit passed all tests.The returned motor 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 motor 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.

Manufacturer Narrative

Section d3: corrected data.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8747818
• MDR Text Key: 149622935
• Report Number: 2916596-2019-03004
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• 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

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR