MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 102954

Device Problem No Audible Alarm (1019)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

The serial number of the console was not yet provided.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 patient had hemodynamic compromise.The patient needed inotropic and ventilatory support.There was no data available on medications.The patient had an acute respiratory distress syndrome (ards) diagnosis due to covid.The patient was rescued by another institution.When the patient arrived at the clinic suddenly the motor stopped and the console did not emit any alarm/alert.The motor was immediately changed, which worked, but the flow probe did not register the flow.The flow probe was changed, but it still did not register flow.The console was changed and it worked without a problem.The support was re-established.The patient was was in critical care for basic pathology in veno-venous extracorporeal membrane oxygenation (vv ecmo).The patient was stable after inotropic and ventilatory support.Related manufacturer report number of motor: 3003306248-2021-05721 related manufacturer report number of flow probe: 3003306248-2021-05723.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the console not alarming was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6)) was not returned for analysis.Additional provided information communicated on 25jan2021 stated that the unit was being returned for evaluation.Only the motor was returned to abbott, and to date the console and flow probe was not received at abbott.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 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 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." the 2nd generation centrimag system operating manual table 13 entitled ¿console alarms & alerts¿ details the various alarms and alerts and the appropriate operator response, including m2 alarms.The 2nd generation centrimag system operating manual section 6.7.4 entitled ¿alarm and alert conditions¿ state that ¿audible and visual alarm/alert conditions warm the operator that may interrupt patient support or damage the pump or console.Depressing the alarm acknowledge keypad mutes the audible alarm.¿ no further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was stable without complications related to the event.

• Brand Name: CENTRIMAG 1ST 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: 12876211
• MDR Text Key: 285940628
• Report Number: 3003306248-2021-05722
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140672
• UDI-Public: 07640135140672
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102954
• Device Catalogue Number: 102954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2018
• 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): Required Intervention