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

Model Number 102956

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 10/03/2020

Event Type  malfunction  

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 rotations per minute could not go above 3000 despite being set at 4800.The chief of perfusion suspected that the motor is faulty, and wants it to be evaluated.The motor was exchanged and new motor functions as expected.

Manufacturer Narrative

Section a: no patient was involved in the event.Manufacturer's investigation conclusion: the reported event of the centrimag motor being unable to be set at speeds above 3000 rpm was confirmed.The returned centrimag motor was functionally tested.An open line was observed within the motor¿s cable, correlating to the motor¿s drive phase (green and yellow wires).Throughout some testing, the motor was able to operate at various speeds, including speeds that ranged between 3000 ¿ 5500 rpm, even while the motor¿s cable was manipulated.However, the reported event was reproduced at the service depot, and manipulating the motor¿s cable was found to cause speed and flow fluctuations while the motor was in use.As a result, the root cause of the reported event was determined to be wire fatigue within the motor¿s cable, causing an intermittent issue that would not allow the pump speed to be consistently set.The motor was scrapped, and the customer was notified of the disposition.Review of the device history record for centrimag motor s/n (b)(6) showed the device was manufactured in accordance with manufacturing and qa specifications.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 CH-80 05; SZ CH-8005
• MDR Report Key: 10726742
• MDR Text Key: 212851540
• Report Number: 3003306248-2020-00093
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• 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
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2020
• 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