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

Model Number 201-30500

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

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 the patient was connected to centrimag (cmag) unilateral support and was transported from operating room to intensive care unit.While the patient was transported, the cmag monitor need to be restarted 10 to 15 times.After the cmag monitor stabilized, an icon "cf x" (crossed square) appeared at the bottom of the monitor.The support of the patient was not interrupted and stable at all time with no change in therapy.The device will not be returned for evaluation as the issue disappeared, and the device is working as intended.

Manufacturer Narrative

Section h4: additional information.Manufacturer's investigation conclusion: the report of a centrimag mag monitor displaying a fault at the bottom of the monitor was confirmed through the analysis of a submitted picture, which showed an active compact flash card (cf) fault (cf with an x icon).This fault status indicates an issue with the mag monitor's compact flash card or a communication issue with the card.The centrimag mag monitor (sn (b)(6)) was not returned for analysis.Per reported information, the mag monitor will not be returned as the described issue disappeared and monitor is working well.As a result, the root cause of the reported event could not be conclusively determined.No further issues have been reported at this time.Reports of similar events will continue to be tracked and monitored.The centrimag 2nd gen system operating manual section 3.1.3-"mag monitor" states "should the mag monitor be disconnected or fail, the 2nd generation centrimag primary console may be operated independently with the relevant operational data displayed on the console display.When the mag monitor is active, control of motor and pump function may be accomplished using either the mag monitor or the console.If a mag monitor is unavailable, the pump and motor can be controlled via the 2nd generation centrimag primary console.When operated in this manner, a number of features that can only be accessed via the mag monitor will not be available.These include; stopwatch function (section 5.14), graphical displays of the pressure, as well as flow and alarm limits.".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: 9383131
• MDR Text Key: 168211584
• Report Number: 2916596-2019-05416
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1