MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR

Catalog Number 102956

Device Problem Pumping Stopped (1503)

Patient Problems Low Blood Pressure/ Hypotension (1914); Anxiety (2328)

Event Date 11/24/2015

Event Type  Injury  

Manufacturer Narrative

Device was manufactured prior to udi labeling implementation.The centrimag motor is not a single use device.The approximate age of the device from the date of manufacture is 3 years.The device was evaluated at the user facility site; however, the manufacturer's investigation is not yet complete.Upon evaluation of the motor, the manufacturer¿s technical services representative verified damage to the motor cable at the bend relief and the motor was scrapped.No further information was provided.Supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was supported by an extracorporeal circulatory support device.It was reported that low pump flows were observed and the primary console alarmed for system failure.The pump speed and flow values were both reading 0 and a ¿motor error¿ message was being displayed.The patient¿s mean arterial pressures were in the 80¿s mmhg at the time of the event.The patient remained awake, but was reportedly distressed while the motor was exchanged.Once the motor was exchanged and flow was restored, the mean arterial pressure returned to the patient¿s baseline in the 90¿s and 100¿s mmhg.No subsequent events were reported.

Manufacturer Narrative

Device evaluation: the reported event was confirmed during the evaluation of the motor at the user facility site.The analysis verified that manipulation of the motor cable near the bend relief caused a system fault error to occur.A specific cause for the cable damage could not be conclusively determined.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The instructions for use instructs the user to inspect the motor, motor cable, console connector and locking mechanism for any damage prior to use and to not use the motor if any component is damaged.The instructions for use also instructs the user to always have a spare motor and back-up equipment available for exchange.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 651756-407
• MDR Report Key: 5426463
• MDR Text Key: 37836910
• Report Number: 2916596-2016-00256
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 102956
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 50