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

Model Number 102956

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

There was no patient involved approximate age of device - age of device will be updated once the manufacturer's investigation is complete.The device was returned for investigation.The evaluation is not yet complete.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 centrimag motor was "not connected" while connected to the console during a routine check.Per customer, when doing a routine check for other centrimag pumps, they connected fine with the console.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the reported event of motor not connected alarms when the motor is connected to the console was confirmed.The centrimag motor (serial #: (b)(4)) was returned for analysis.The motor underwent resistance and insulation testing.The motor passed resistance testing.The motor failed insulation testing at the following connections: emc to b2+/b2- and agnd to b2+/b2-, indicating conductor breakdown in the motor cable.The motor was forwarded to the service depot for analysis.The service depot was able to verify and duplicate the reported event.Motor was connected to a test 2nd generation console and flow probe and the motor disconnected (m2) and system alert (s3) alarms activated.The root cause for the motor disconnected alarms was conclusively determined to be due to conductor breakdown in the motor cable.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: 8611848
• MDR Text Key: 145108994
• Report Number: 2916596-2019-02122
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 05/01/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention