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

Catalog Number 102954

Device Problems Device Stops Intermittently (1599); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/14/2016

Event Type  Injury  

Manufacturer Narrative

The referenced back-up primary console that failed was reported under medwatch mfr report #2916596-2016-02194.The primary console is not a single use device.The serial number of the device was not provided, therefore the approximate age of the device, manufacture date and device unique identifier (udi) are unknown.The device is expected to be returned for analysis.It has not yet been received.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 left ventricular extracorporeal circulatory support on (b)(6) 2016.It was reported that on (b)(6) 2016, the primary console "failed." the pump speed and pump flow remained at 0 rpm and 0 lpm respectively.The patient was switched to the back-up primary console which also failed.Therapy was restored when the patient was switched to a third primary console.It was reported that the patient was symptomatic; however, the specific symptoms were not provided.It was reported that the user facility believed that the issue may be due to battery maintenance, which is being addressed by ensuring that battery maintenance is being done routinely and properly.No additional information was provided.

Manufacturer Narrative

The device was not available for evaluation.As a result, the reported event could not be confirmed and the root cause could not be conclusively determined.It was reported that the hospital's biomedical engineer performed a functional checkout and replaced the backup battery of the device.The device serial number was not provided; therefore, review of the device history records could not be performed.The manufacturer is closing the file on this event.

Event Description

Additional information: it was reported that the hospital's biomedical engineer performed testing of the device on a mock circulatory loop and completed a functional checkout.The backup battery was reportedly replaced during this procedure and the device would not be returned.Additional information was requested but not provided.The patient's symptoms were not specified and the serial number of the primary console was not provided.

• Brand Name: THORATEC CENTRIMAG PRIMARY CONSOLE
• Type of Device: CENTRIMAG PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; ch-8005 zurich ; SZ
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564071
• MDR Report Key: 6092758
• MDR Text Key: 59604012
• Report Number: 2916596-2016-02193
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 02/13/2017
• 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 Outcome(s): Hospitalization; Required Intervention