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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE Back to Search Results
Model Number 201-30300
Device Problems Pumping Stopped (1503); Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2018
Event Type  malfunction  
Manufacturer Narrative
The event occurred at (b)(6). 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 extracorporeal circulatory support on (b)(6) 2018. It was reported that the primary console alarmed with error code b1 while in use supporting a patient. The primary console was switched to the backup system. The pump worked normally with the replaced primary console. The patient was not harmed or injured due to the event. No additional information was provided.
 
Manufacturer Narrative
Manufactures investigation conclusion: the centrimag primary console was not returned for analysis and no log files were submitted for the event. As a result, the reported event could not be confirmed and a root cause could not be conclusively determined. However, per reported information, an engineer on site performed battery maintenance and the unit passed. The engineer also operated the console and battery with a test loop and both devices worked without any issues. Since the system operated as intended, the customer was informed that they did not have to return the unit. Reports of similar events will continue to be tracked and monitored. The 2nd generation centrimag system operating manual (doc. #pl-0280, rev. 05) section 7. 3-"recommended preventative maintenance" contains table 16, which states that battery maintenance should be performed every 6 months and that the internal battery (internal rechargeable battery pack) should be replaced every 2 years. A review of the device history records revealed the device met applicable specifications. No further information was provided. The manufacturer is closing the file on this event.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of DevicePRIMARY CONSOLE
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ CH-8005
MDR Report Key7697025
MDR Text Key114555565
Report Number2916596-2018-02656
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,distri
Type of Report Initial,Followup
Report Date 10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30300
Device Catalogue Number201-30300
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/17/2018 Patient Sequence Number: 1
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