MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Model Number 102956

Device Problems Fracture (1260); Mechanical Problem (1384)

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

Event Date 07/29/2019

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 the locking screw on the motor was broken.The unit was sent in for repair.No additional information was reported.

Manufacturer Narrative

Device evaluation: the report of a broken centrimag motor locking screw was confirmed during the investigation of the returned centrimag motor.The returned motor was evaluated and tested by the service depot.The reported complaint was verified.Visual inspection confirmed that the motor's locking screw was broken off.The defective locking feature was replaced with a new one.The motor was then operated with a test console and flow probe and it operated successfully at all flow speeds.No error codes nor issues were observed.Visual inspection of the motor's cable did not reveal any issues.Full functional checkout was performed per the centrimag motor service process and the unit passed all tests.The serviced and tested motor was returned to the customer site.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on the event.

Manufacturer Narrative

Section b5: additional information.Section d3: correction.

Event Description

It was reported that when the centrimag pump was being placed inside the motorhead, the pin could not be tightened or loosened, it was stuck in the same position.Without the pin to stabilize the pump head, we used another motor for patient care instead.Since then, the motor head was sent back to abbott, repaired, and is back with the customer.The device was not connected to a patient when the issue occurred.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8910549
• MDR Text Key: 154878627
• Report Number: 2916596-2019-03906
• Device Sequence Number: 1
• Product Code: DWA
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• 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: 08/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1