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

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.

• Brand Name: PRIM CONS 1ST GEN, STANDALONE
• 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: 8566799
• MDR Text Key: 143617546
• Report Number: 2916596-2019-02166
• 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: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 68