MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH MAG MONITOR; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30500

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

No patient was involved with the event.Manufacturer's investigation conclusion: the report of a centrimag mag monitor operating in a loading loop and not booting up fully was confirmed and reproduced during testing of the returned mag monitor (sn (b)(4)).The returned monitor was first received by the service depot.Upon arrival the mag monitor was checked for damage and none was observed.The unit was powered on.However, the unit did not boot up fully, confirming the reported event.The unit was forwarded to mcs zurich for troubleshooting and repair.The returned mag monitor was evaluated and tested at mcs zurich.The monitor was connected to a 2nd gen primary console via a test monitor cable.The console was connected to ac power and switched on.After powering the console on, the returned monitor started up but displayed a "loading application." message and re-booted in a continuous loop.This fault occurred when both the left and right side monitor connections were used.The reported event was confirmed.The mag monitor was then disassembled in order to inspect its internal components.No connection issues nor visible damage were observed.The monitor pre-assembly printed circuit board (pcb) was removed and powered with a test monitor cable and a test "cable-lemo input", revealing that the reset-led on the cpu module was blinking in an interval of ~1 second on and ~30 seconds off.This was consistent with the observed continuous reset cycle.Further testing revealed that the exm32 cpu-module (sn (b)(4)) was responsible for the fault.The exm32 cpu-module is an externally supplied part.No circuit diagrams of the module are available.Therefore, no further analysis of the module could be performed.The root cause of this part being defective could not be conclusively determined during the investigation.The cpu-module was received at mcs zurich in december 2016.The manufacturer of the cpu-module provided a warranty guarantee until 31dec2018, and it was noted that this warranty has been exceeded.Review of the monitors device history record (dhr) revealed that it passed all tests prior to being sent to the customer.As a result, the root cause of the observed pcb damage could not be conclusively determined.The defective exm32 cpu-module was replaced with a new one, resolving the issue.The repaired unit was functionally tested and always operated as designed.The repaired and serviced unit was returned to the customer site.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.

Event Description

It was reported that the centrimag monitor was stuck in a loading loop and would not fully boot up.A different monitor was tested with the same cables and it booted up without issue.The suspect monitor was returned for evaluation.No additional information was provided.

• Brand Name: MAG MONITOR
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• 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: 9961755
• MDR Text Key: 190940298
• Report Number: 2916596-2020-02124
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/15/2020

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: 201-30500
• Device Lot Number: L06540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2020
• Initial Date FDA Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2019
• 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