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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH PRIM CONS 1ST GEN, STANDALONE PRIMARY CONSOLE

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THORATEC SWITZERLAND GMBH PRIM CONS 1ST GEN, STANDALONE PRIMARY CONSOLE Back to Search Results
Model Number 201-30100
Device Problems Pumping Stopped (1503); Power Problem (3010)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 01/15/2018
Event Type  Death  
Manufacturer Narrative
The initial submission of this event was reported by the manufacturer under mfr. Report # 2916596-2018-00844. This report is being submitted as additional information. Approximate age of device- 10 years, 6 months. Manufacturer's investigation conclusion: the reported event could not be confirmed nor reproduced during testing of the returned centrimag primary console. The returned console was evaluated and tested by the service depot. The reported event could not be duplicated during their evaluation. The unit's internal battery was allowed to charge for 12 hours. The unit was then turned on and powered up normally without any issues. The console supported a test motor and pump without any issues. A battery minimum run-time test was performed and the unit passed while running a mock circulatory loop at 5000rpm and 9. 01lpm. The unit ran for 48 minutes until a low battery status and ran for a total of 68 minutes until the "battery below minimum" warning activated. No battery malfunction or any other issues were observed during testing. Visual inspection of the unit did not reveal any issues. The unit required battery maintenance, which was then performed without any issues. The returned console was found to function as intended. As a result, the root cause of the reported event could not be conclusively determined. Reports of similar events will continue to be tracked and monitored. Centrimag motor instructions for use instructs to always have a back-up centrimag motor available. Centrimag blood pump instructions for use states "always have a spare centrimag blood pump, back-up console and equipment available for change out. " centrimag primary console operating manual warns "one back-up console and motor are required in the immediate vicinity of each patient whenever the centrimag blood pump is used. The back-up console must be connected to the back-up motor, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the primary console or primary motor experience a malfunction. ". No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
The patient was being supported with an extracorporeal circulatory support pump. It was reported that the centrimag (cmag) primary console had a battery failure that caused a momentary pump stop. The event occurred when the patient was transported for a ct. After 15-20 minutes of being unplugged from ac power, rpms suddenly dropped to 0 and the primary console alarmed ¿battery malfunction¿. There were no other alarms prior to the event. The primary console was plugged back into ac power; however, rpms remained at 0 with message of ¿battery malfunction¿. The pump and motor were then switched to the backup console and the pump resumed. At the time of the pump stop, the patient¿s condition worsened and the patient arrested, but was resuscitated. The patient was stabilized after the pump stoppage and remained on support for several weeks. Per the patient¿s wishes, care was withdrawn on an unspecified date and the patient expired. No further information was provided.
 
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Brand NamePRIM CONS 1ST GEN, STANDALONE
Type of DevicePRIMARY CONSOLE
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ CH-8005
Manufacturer (Section G)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key8566799
MDR Text Key143617546
Report Number2916596-2019-02166
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/30/2019 Patient Sequence Number: 1
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