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

Model Number 201-90411

Device Problems Mechanical Problem (1384); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Related manufacturer reference number: 3003306248-2020-05466.It was reported that about half an hour of regular operation on the centrimag, a loud noise was heard coming from the motor/pump without any alarms.Troubleshooting was performed by stopping the machine in order to reposition the pump but there was no resolution.The process was repeated without success.After the second attempt to reposition the pump, an "engine disconnected" alarm appeared on the console.The motor was exchanged, but the alarm persisted.The console was turned off and then on again to try to reset the system, but no resolution.The console was exchanged.The therapy was restarted.There was no consequences to the patient.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console failing to alarm when expected was not confirmed.The returned centrimag console (serial number (b)(6)) was tested at the european distribution center.The console powered on as intended; however, a system fault alarm unrelated to the reported event became active.Since the 1st generation of centrimag consoles are no longer able to be repaired, the console was unable to be tested further and was scrapped.The root cause of the reported event was unable to be conclusively determined through this analysis.Section 5.4.1, entitled ¿primary console front panel¿ within the centrimag primary console operating manual, instructs users on how to appropriately read information using the centrimag console¿s front panel, as well as with a flow probe accessory.Section 10, entitled "emergency/trouble shooting" of the centrimag primary console operating manual, states: "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 to continue patient support.Do not exchange individual motors or individual consoles during patient support." review of the device history record for centrimag primary console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• 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: 10852793
• MDR Text Key: 244565363
• Report Number: 3003306248-2020-05467
• 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: 02/15/2021

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: 201-90411
• Device Catalogue Number: 201-90411
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 02/08/2021
• Supplement Dates FDA Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR
• Patient Outcome(s): Required Intervention