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

Model Number 201-10003

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 05/21/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned for investigation.The evaluation is not yet complete.Approximate age of device ¿ the centrimag primary console is not a single use device.Approximate age of the device from the manufacture date.This will be completed once investigation is completed.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was being supported with a ventricular assist device for acute support on (b)(6) 2019.It was reported that a call from the bio-med stated that they have a cmag motor with a broken locking screw.It was being sent back for repair.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a broken locking screw was confirmed.The centrimag motor (serial #: (b)(6) was returned for analysis.The motor underwent resistance and insulation testing on the motor cable and passed.The motor was forwarded to the service depot for analysis.The returned motor was evaluated and tested under work order #53755487.The service depot was able to verify the reported event of a broken locking screw and was replaced with a new metal locking feature.The motor was tested successfully at all rpm speeds and no error codes or issues arose.Per field action ¿fa-q318-mcs-1¿, the motor cable was inspected, and no issues were found.A full functional checkout was performed, and the unit passed all tests.The motor was returned to the customer.The root cause for the broken locking set screw was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section d3: g1: correction.

• 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: 8678343
• MDR Text Key: 147314426
• Report Number: 2916596-2019-02450
• Device Sequence Number: 1
• Product Code: KFM
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-10003
• Device Catalogue Number: 201-10003
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 118