• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG PRIMARY CONSOLE INTERNAL BATTERY PACK CENTRIMAG PRIMARY CONSOLE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTHORATEC CENTRIMAG PRIMARY CONSOLE
Type of DeviceINTERNAL 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 Key5636437
MDR Text Key44553014
Report Number2916596-2016-00866
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number104172
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-