MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during routine training two centrimag motors displayed "motor disconnect" alarms when connected to a console.The consoles were double checked with known good motors to verify issue.Two centrimag motors are returning for evaluation.No further information was provided.

Manufacturer Narrative

Manufacturer's aware date was inadvertently omitted from previous report.The correct date was 06nov2019.Manufacturer's investigation conclusion: the report of a motor disconnect alarm could not be confirmed during the investigation of the returned centrimag motor (sn (b)(6)).The returned motor was evaluated and tested by the service depot.The reported issue was not duplicated nor confirmed during testing.The motor was connected to a test console and flow probe.Once powered up, no motor disconnected:m2 fault was observed nor were any other alarms at any point during testing.The motor was functionally tested per the centrimag motor service process and always performed as designed.The motor's cable was inspected and no issues were observed.Continuity and insulation testing of the motor's cable did not reveal any issues.As a result, the root cause of the reported event could not be conclusively determined nor correlated to the returned motor.The motor's cable was found to be broken off and was replaced with a new one free of charge.The tested and serviced motor was returned to the customer site.As an added observation, it was noted that the motor was over 9 years old.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual section 4-"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-"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 has an emergency/troubleshooting section for the 2nd generation console.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 section 12.1-"appendix i - primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 9273319
• MDR Text Key: 164895516
• Report Number: 2916596-2019-04995
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 10/15/2019; 01/17/2020
• Supplement Dates FDA Received: 11/06/2019; 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1