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

Model Number L201-90411

Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190)

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

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

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 centrimag showed an audible alarm with a blue picture of the plug-cord and a countdown of 3.5 hours of battery power to confirm that the console was unplugged while the centrimag console was still plugged in.This event occurred twice within a 24 hour period and then continued to occur.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the console operating on battery power despite the console being connected to ac power was not confirmed.The centrimag 2nd generation primary console (serial#: (b)(6) was not returned for analysis.Additional provided information communicated on 12may2022 stated that the customer will not be returning their equipment for evaluation and the issue resolved on its own.The root cause for the reported event was unable to be determined through this analysis.The device history records were reviewed for the centrimag 2nd generation primary console (serial#: (b)(6) and the console was found to pass all manufacturing and qa specifications.The 2nd generation centrimag system operating manual 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 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." no further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis to the service depot.The reported event of the console alarming to confirm the console has been unplugged could not be duplicated.The console was connected to a test loop and run for several days.During observation, there were no alarms or loss of power.The console was functionally tested and passed all tests.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 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: 14244407
• MDR Text Key: 290543185
• Report Number: 3003306248-2022-00061
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2022

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 Model Number: L201-90411
• Device Catalogue Number: L201-90411
• Device Lot Number: 7787068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2022
• Initial Date FDA Received: 04/28/2022
• Supplement Dates Manufacturer Received: 05/17/2022; 08/01/2022
• Supplement Dates FDA Received: 05/24/2022; 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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