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

Model Number 201-30300

Device Problems Disconnection (1171); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2019

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that motor disconnect m2 alarm was observed during the self-check.The system was turned off, and replugged both motor and flow probe.The m2 alarm still returned even when switching to another motor.There was no problem with the first motor when connected to a different console.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of a motor disconnected: m2 alarm observed during the self-check despite a motor being connected was confirmed and reproduced during testing of the returned centrimag 2nd gen primary console (sn: (b)(6).The returned console was evaluated and tested at mcs zurich under rma 19-112.The console was visually inspected and found to be in good condition.The console's log file was downloaded successfully.Per provided information, the reported event occurred on (b)(6) 2019.The retrieved data log file showed that the console had successfully passed a battery maintenance on 06sep2019.On 09sep2019 the console was again switched on.After the start-up sequence the console alarmed with a motor disconnected: m2 and flow sensor disconnected: f2 alarms.However, the analysis of the logged tech auxiliary data showed that the lmc motor temperature was between 26c and 27.8c, confirming that the motor was connected to the console at this point of time.(note: when no motor is connected to a 2nd gen console the value for the lmc motor temperature is at the end of the register range, which is -128c).Based on this temperature value it can be determined whether or not a motor was likely to have been connected.The log file confirmed the reported event.The console did not recognize the connected motor and alarmed with a motor disconnected:m2 alarm.The returned console was connected to mains power and powered on.After the start-up sequence, the console alarmed with a motor disconnected: m2 and flow sensor disconnected: f2 alarms, as intended because neither a motor nor a flow probe was connected.Then, a test motor and test flow probe were connected to the console.The flow sensor disconnected: f2 alert disappeared as intended.However, the motor disconnected: m2 message remained being displayed on the console and the "set rpm" option was not available on the console's display, reproducing the reported issue.Further testing revealed that the motor phase a h-bridge on the console's motor control (lmcebpx) printed circuit board (pcb) was defective.This caused the power stages to be disabled and the subsequent "motor disconnected: m2" alarm to be triggered.The root cause of the h-bridge for motor phase a becoming defective could not be conclusively determined during the investigation.The defective motor control pcb (lmcebpx pcb) was replaced with a new one, resolving the observed issue.Additionally, the cable "lemo motor interconnection" was also replaced with a new one, but only as a preventative action, because the cable was stressed during the investigation.Furthermore, the console's battery was noted to be near its expiration date (31may2020) and was replaced with a new one.The repaired and serviced console was then subjected to the repair and maintenance procedure and the unit passed all tests.The serviced and tested unit was returned to the distribution center for final processing and disposition.Reports of similar events will continue to be tracked and monitored.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: 9150951
• MDR Text Key: 162451736
• Report Number: 2916596-2019-04487
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

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: Other
• Device Model Number: 201-30300
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1