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

Model Number 201-90411

Device Problems Pumping Stopped (1503); Infusion or Flow Problem (2964); Insufficient Information (3190); Unexpected Shutdown (4019)

Patient Problem Chest Pain (1776)

Event Date 01/19/2022

Event Type  Injury  

Manufacturer Narrative

Patient information was requested but not yet provided.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that an issue was experienced with the centrimag console and flow probe system.The 2nd generation console experienced a malfunction.A nurse was preparing the patient for a transport and the only thing that occurred up to that point was that the centrimag monitor cable was disconnected from the affected console.An alarm condition sounded and the alarm was unknown.The patients rotations per minute and flow decreased to zero from previous setting of 4300 rpm and 5.3 liters per minute of flow.An extracorporeal membrane oxygenation (ecmo) specialist noted that the driveline and pump head were properly seated in their retrospective connections and motor.The specialist immediately increased the rotations per minute back to prior level of 4300 but there were no noted flows.It was not reading zero flow or symbol for retrograde flow.There was a blank field where flows should have been displayed.The specialist felt something when feeling for slight vibration of the motor.The patient was on a bi-ventricular assist device (bivad) system and the right vad flow probe was moved from one of the patients cannula lines while the new probe was attached to the right vad console to the circuit lines to see if there was flow in the lvad system.An appropriate amount of flow was displayed.Another flow probe was obtained from the backup system and when attached to the console there were still no flow readings.The specialist then disconnected the flow probe from the right vad temporarily and placed it on the affected console and again the were no flows registered on the affected console.The patient had stabilized and experienced increased chest pain and tinnitus during the short period of times when the flows were zero.The affected console was changed out to the new console, which was functioning well so far.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the motor speed and flow dropping to 0 rpm and 0 lpm respectively and an unknown alarm was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis to the service depot and was evaluated and tested.The reported event was unable to be reproduced.The unit was functionally tested and operated as intended.The console was returned to the rental pool.The root cause for the reported event was unable to be conclusively 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 (rev.M) 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." the 2nd generation centrimag system operating manual (doc.#pl-0047 rev.M) section 10 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.

• 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
• 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: 13401504
• MDR Text Key: 289285232
• Report Number: 3003306248-2022-00006
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2013
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 83 KG