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

Model Number L201-90411

Device Problems No Display/Image (1183); Failure to Interrogate (1332)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved in this event.The pma# provided is associated with the device's most recent approval.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the mag monitor would not respond when it was plugged in to the console, but it did work when plugged into another console.It was stated that the issue was most likely with the console mag monitor port.The unit would be returned, and another console would be sent as replacement.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag 2nd generation primary console not responding was not confirmed.The centrimag 2nd generation primary console (serial number (b)(6)) was returned and evaluated at the service depot.During the evaluation, the reported event could not be reproduced.The returned console and the returned monitor cable (investigated in (b)(4)) were connected to a test loop and ran for several days.During operation, no alarms were observed on the console or test monitor and both products operated as intended.The returned monitor cable was inspected and was found to be in good condition.The console was functionally tested and passed all tests without issue.The console is ready for use and will be returned to the rental pool.Multiple attempts were made to obtain additional information about the reported event such as if this event occurred while a patient was connected to the unit or during initial setup, if any troubleshooting was performed, if there was any damage to the unit, and if any product will be returned for analysis; however, no response was given.The root cause of the reported event could not be conclusively determined through this analysis.Review of the device history record for the centrimag 2nd generation primary console , serial number l03065-0008, showed the device was manufactured in accordance with manufacturing and qa specifications.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 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." no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA 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: 15572295
• MDR Text Key: 306509977
• Report Number: 2916596-2022-14155
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

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 Expiration Date: 12/31/2022
• Device Model Number: L201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 7683272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/10/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1