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

Model Number 201-30500

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer investigation conclusion: the reported event of one of the monitor¿s connections not working was confirmed.The centrimag monitor (serial #: (b)(4)) was returned for analysis to mcs zurich and was investigated.The returned monitor was connected to a test console using the right-side input and a test monitor cable and the monitor was able to start up and it operated as intended.However, when using the left-side input, the monitor started up and immediately the monitor screen went dark.This occurred each time the monitor was power-cycled using the left-side input.The left-side power input-cable, lemo-to-pcb cable, was replaced with a new one.The monitor was powered on and the same problem occurred.The interior of the monitor was then inspected.The pre-assembled monitor printed circuit board (pcb) was disassembled, and the left and right power inputs were connected via and external test lemo-to-pcb cable and test monitor cable.A visual inspection of the pcb was performed.Traces of burns and damage to the chip housing were seen on the integrated circuit (ic) ¿u701¿, the can-bus transceiver in the left-side input lines.The defective u701 chip was removed and replaced with the right-side can-transceiver, ¿u700¿.The monitor was reassembled and rebooted using the left-side input.The monitor functioned as intended and confirmed that u701 was the only defective component on the board.The pre-assembled monitor pcb was replaced with a new one.The repaired monitor was retested.It was connected to its left and right-side connectors 5 times each and the monitor started up and operated as intended.The fault did not reoccur.The monitor was subjected to the reprocessing and maintenance procedure and the final test.The monitor passed all tests.The monitor was returned to the distribution center.The root cause for the reported event was conclusively determined to be due to damage to the pre-assembled monitor pcb.No further information was provided, the manufacturer is closing the file on this event.

Event Description

It was reported that one of the monitor's connections didn't work.The information provided by the console was not displayed on the monitor.The account tried new cables but the problem remained unsolved.No further information was provided.

Event Description

Related manufacturer report number: 3003306248-2021-02969.

Manufacturer Narrative

The root cause for the reported event was conclusively determined to be due to the console to monitor cable not being assembled correctly at manufacturing.The monitor cable was investigated under manufacturer report number 3003306248-2021-02969.Additional information to the manufacturer's investigation conclusion: the device history records were reviewed for the centrimag monitor (serial #: (b)(6)) and the monitor was found to pass all manufacturing and qa specifications prior to being shipped to the customer on 07oct2016.The 2nd generation centrimag system operating manual section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, 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 main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.The 2nd generation centrimag system operating manual section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

• 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
• MDR Report Key: 11012798
• MDR Text Key: 229153768
• Report Number: 3003306248-2020-06196
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30500
• Device Catalogue Number: 201-30500
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1