MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90411

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier, age or date of birth, sex, weight: patient information not provided.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that a cmag unit shut down during support and gave a battery module fail indication.No additional information was reported.

Manufacturer Narrative

Section g5: additional information.Manufacturer's investigation conclusion: the report of a "battery module fail indication" was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console (sn (b)(6)).Per the log file, on (b)(6) 2019 the console was supporting a system while being supported by its internal battery.At ~11:56am on (b)(6) 2019 the system was stopped and the console appears to have been powered down.At this point the battery's relative state of charge (rsoc) was captured at ~60%.The system was powered back on at ~9:35am on (b)(6) 2019 and the battery's relative state of charge was captured at 0% with a "battery time to empty" at 0min, indicating that the internal battery was fully depleted.Approximately 2 minutes after being powered up the console alarmed with a battery module fail:b1 alarm as a result of an active sf_sps_battery_selftest fault.The console's internal battery appeared to have failed the self-test as a result of being fully depleted.Although the root cause of the console's internal battery being fully depleted could not be conclusively determined, it appears that the console was never reconnected to ac power once powered down on (b)(6) 2019.The returned console was evaluated and tested by the service depot.The reported complaint could not be duplicated during their evaluation.However, it was noted that the console was in need of a software update.The software update was performed successfully.The console was operated with a test motor and flow probe without any issues being reproduced.Full functional checkout was performed per the centrimag 2nd gen primary console service process and the unit passed all tests.The returned console was found to function as intended.The serviced and tested console was returned to the customer site.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual section 7.5-"7.5 powering up" states: "check the power status on the 2nd generation centrimag primary console front panel to verify that the green ac power on indicator is illuminated.The console should be connected to ac power for at least twelve hours prior to use to recharge the internal battery and to ensure battery power availability, when needed." this document also cautions that "whenever the unit is not attached to ac power, regardless of whether the 2nd generation centrimag console is on or off, the battery will discharge.The rate of battery discharge will be greater if the console is on.In order to prevent unintentional discharge of the battery, always leave the unit plugged in to ac power.The console must be connected to ac power to charge or maintain the battery charge, but does not need to be powered on.".No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9311020
• MDR Text Key: 166358049
• Report Number: 2916596-2019-05311
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• PMA/PMN Number: K102129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 02/14/2020
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1