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

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broken/missing from the enclosure.Due to no replacement parts being available and this unit's software version being an outdated version 3.00, the unit is no longer supported.As a result, the unit was scrapped.No further information was provided.The manufacturer is closing the file on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.

• Brand Name: CENTRIMAG 1ST GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY 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 Key: 8659916
• MDR Text Key: 146776588
• Report Number: 2916596-2019-02612
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 102954
• Device Catalogue Number: 102954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2008
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR