MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG PRIMARY CONSOLE; INTERNAL BATTERY PACK CENTRIMAG PRIMARY CONSOLE

Catalog Number 104172

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

Patient Problem No Information (3190)

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, 4 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 pump.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.Information regarding any impact to the patient was requested but was not provided.Prior to the event, the console had remained plugged in until actual ambulation.The center's biomedical engineering department reported that the console ran approximately 12 minutes on battery.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

Device unique identifier (udi) ¿ the device manufacture date was unknown; however the centrimag primary console internal battery pack was shipped to the customer on 05/07/2013.Approximate age of device - the centrimag primary console internal battery pack is not a single use device.Approximate age of the device from the ship date is 2 years, 10 months.The centrimag primary console and the centrimag primary console internal battery pack were returned for evaluation.The centrimag primary console was evaluated and functioned as intended with no issues.Evaluation of the returned centrimag primary console internal battery pack confirmed the event of the centrimag primary console being unable to operate on battery power; however, the report that the system did not alarm for low battery was unable to be reproduced during analysis.Upon receipt, the centrimag primary console internal battery pack was found to have an open circuit voltage of 21.35 volts.Upon connection of the battery to a test centrimag primary console, the primary console alarmed with a battery maintenance required message and one red battery on the battery gauge.The battery was left to charge and after charging, the battery maintenance procedure was performed to evaluate battery run time.The battery ran for only 3 minutes 53 seconds before alarming with a low battery alarm.The battery was over two years old and the battery run time was found to be out of specification.During testing, the appropriate audio and visual alarms were observed on the test primary console.A review of the device history records for both the centrimag primary console and the centrimag primary console internal battery pack 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: INTERNAL BATTERY PACK 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: 5636437
• MDR Text Key: 44553014
• Report Number: 2916596-2016-00866
• 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: 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: 104172
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• 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: 10/01/2009
• 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