MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG PRIMARY CONSOLE

Catalog Number 102954

Device Problems Premature Discharge of Battery (1057); Device Stops Intermittently (1599)

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

Event Date 11/15/2015

Event Type  malfunction  

Manufacturer Narrative

The device serial number was not provided.As a result, the device manufacture and expiration dates, the approximate age of the device, and the device unique identifier are not available.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 an extracorporeal circulatory support device on (b)(6) 2015.It was reported that on (b)(6) 2015, 5 minutes into patient transport to the operating room from the intensive care unit, the battery on the patient's primary console suddenly depleted and the console shut down without warning.The patient was without support for approximately one minute but remained stable and asymptomatic.The console was reconnected to an outlet as soon as patient arrived in the operating room and the console was exchanged during the unspecified operating room procedure.It was reported that there was no issue with the battery on the new console during transport back to the intensive care unit.The battery on the patient's initial primary console was exchanged at the hospital.

Manufacturer Narrative

The reported event could not be confirmed and a root cause could not be conclusively determined as the device was not returned for evaluation.The event could not be correlated to a device related issue.It was reported that the battery exchanged an the device remains in use.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG PRIMARY CONSOLE
• Type of Device: CENTRIMAG PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zürich 8005 ; SZ 8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 5289708
• MDR Text Key: 33287362
• Report Number: 2916596-2015-02352
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102954
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR