MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION ADULT FLOW PROBE 1/4; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 104298

Device Problems Inadequate Instructions for Healthcare Professional (1319); Device Markings/Labelling Problem (2911)

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

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved in the event.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 product was defective out of the box.The flow probe was placed back in the box an labeled as defective.The flow probe did not include a manufacture label.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of an out of box issue and the centrimag flow probe missing its manufacturing label were not confirmed as the centrimag flow probe was not returned for analysis and no log files were submitted for review.Multiple attempts were made to obtain additional information (including if there was an out of box issue with the flow probe and if the manufacturer label was missing); however, no response was received.The root cause of the reported events could not be conclusively determined through this analysis.The 2nd generation centrimag system operating manual (rev.11) section 10 ¿ ¿emergencies/troubleshooting¿ provides instructions for operation when there is a need to exchange the main console or motor with a backup console or motor.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 (rev.11) section 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), including flow related alarms, and the appropriate actions to take if the issue does not resolve.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 1ST GENERATION ADULT FLOW PROBE 1/4
• 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: 11849438
• MDR Text Key: 253813055
• Report Number: 3003306248-2021-01107
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140146
• UDI-Public: 07640135140146
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 104298
• Device Catalogue Number: 104298
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1