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

Catalog Number 102954

Device Problems Battery Problem (2885); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

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

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

Patient demographics were requested but were not provided.Device unique identifier (udi) - device was manufactured prior to the udi labeling implementation.Approximate age of device - the centrimag primary console is not a single use device.Approximate age of the device from the ship date is 6 years, 8 months.The device was returned for investigation.The evaluation is not yet complete.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was being supported with an extracorporeal circulatory support device.It was reported that the primary console turned off when ambulating the patient.The console's battery reportedly died without any warning alarm that the battery was low.There was no reported adverse patient impact.Prior to the event, the console had remained plugged in until actual ambulation.The center's biomedical engineering department reported that the console ran less than 5 minutes on battery power.They confirmed that the battery was two or more years old.It was reported that the biomedical department plans to change out the batteries every 1.5 years to prevent future occurrences.Further information was requested but not provided.

Manufacturer Narrative

The report of the centrimag primary console being unable to operate on battery power and not alarming for a low battery could not be confirmed or reproduced through the evaluation of the returned centrimag primary console.The battery maintenance procedure was performed to evaluate battery run time, and the unit passed with no issues.It was reported that the centrimag primary console had a battery replacement after the incident occurred.The battery that was in the primary console at the time of the event was not returned for evaluation; however, it was reported that the battery was over two years old.A review of the device history records showed no deviations from manufacturing or qa specifications.No further information was provided.The manufacturer is closing its file on this event.

• Brand Name: THORATEC CENTRIMAG PRIMARY CONSOLE
• Type of Device: CENTRIMAG PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; technoparkstrasse 1; pleasanton CA 94588
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 651756-407
• MDR Report Key: 5636442
• MDR Text Key: 44553081
• Report Number: 2916596-2016-00865
• 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: 04/07/2016

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 Catalogue Number: 102954
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 05/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2008
• 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