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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE

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THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE Back to Search Results
Model Number 102954
Device Problems Pumping Stopped (1503); Power Problem (3010)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 12/13/2016
Event Type  Death  
Manufacturer Narrative
The initial submission of this event was reported by the manufacturer under mfr. Report # 2916596-2017-00058. This report is being submitted as additional information. Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation. Approximate age of device - the primary console is not a single use device. Approximate age of the device from the manufacturer date is 8 years and 5 months. Manufacturer's investigation conclusion: the report of a "battery below minimum" alarm and unexpected console shutdown was confirmed and reproduced during testing of the returned centrimag primary console (serial number (b)(4)). The returned console was evaluated and tested by the service depot. The unit's internal battery was allowed to charge for 12 hours. The unit was turned on and powered up normally. The unit operated the test pump and motor on a mock circulatory loop without any issues. Battery minimum run-time test was performed but the unit failed the test when running the system at a speed of 5000rpm and flow of 9. 01lpm. During the run-time test, the unit operated for 29 minutes to a "low battery" status and ran for a total of 43 minutes to the "battery below minimum" warning. This was below the minimum required 50 minute run-time total specification. Review of the maintenance history card on the unit showed that the last battery replacement was performed on march 18, 2015. Additional testing of the console isolated the battery run-time issue to the console's internal rechargeable battery pack. Although the root cause of the battery being defective could not be conclusively determined, it appeared to be a result of the battery being used outside of recommended usage time outlined in the console's operating manual. The centrimag primary console operating manual table 13 instructs users to replace the internal rechargeable battery pack every two years. Battery performance outside of that time frame cannot be guaranteed. The unit was inspected further and it was observed that two grounding blocks were broken/missing from the enclosure. Due to no replacement parts being available and this unit's software version being an outdated version 3. 00, the unit is no longer supported. As a result, the unit was scrapped. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
The patient was supported by an extracorporeal circulatory support device. It was reported that the patient had been on extracorporeal membrane oxygenation (ecmo) for approximately 100 days. The patient had recently been transferred from another hospital. The patient was positive for heparin induced thrombocytopenia. During transport for a ct scan, the charge of the battery on the primary console was full per the battery fuel gauge. After 2 minutes on battery power, the system alarmed "battery below minimum". It was reported that there was zero flow and pump stoppage occurred; however, the battery display still read full charge. The patient was gray in color, and chest compressions were performed for approximately 1 minute. It was reported that the patient was off device support for approximately 4 minutes. It was reported that the motor was very hot. The hospital clinicians changed the primary console and motor. It was reported that the device functions as expected after the equipment was exchanged, and the patient was back to baseline after the event. The patient expired a few days later after the family electively withdrew care. The vad team does not believe the incident led to the patient¿s death. No additional information was provided. A user facility medwatch report was received subsequent to the initial manufacturer medwatch submission which stated: pt was being transported while on centrimag ecmo. Machine was using its battery life. Pump stopped forward flow and alarmed "battery below minimum", though the indicator displayed a full charge battery. Drive head was switched out and placed on back-up battery. Cpr was initiated for pt and flow restored.
 
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Brand NameCENTRIMAG 1ST GENERATION PRIMARY CONSOLE
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 Key8659916
MDR Text Key146776588
Report Number2916596-2019-02612
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 05/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number102954
Device Catalogue Number102954
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2008
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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