MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR; DWA: CENTRIMAG MOTOR

Model Number 102956

Device Problems Thermal Decomposition of Device (1071); Circuit Failure (1089); Loss of Power (1475)

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

Event Date 09/09/2013

Event Type  malfunction  

Event Description

The patient was being supported with a paracorporeal ventricular assist device for acute support.The chief perfusionist reported that the primary console was alarming "motor disconnected" despite the motor being connected.The speed went to 0 and flow read ---.Upon seeing the alarm message, the chief perfusionist rebooted the primary console by turning it off and powering it back on.Once rebooted, the console immediately started alarming with "motor disconnected".The pump was transferred to the back-up console and back-up motor.When powered on, the back-up console started alarming "system fault", "flow signal fail", "battery charge fail" and "battery maintenance required" (despite battery maintenance having been performed recently).The hospital staff connected the back-up motor to the primary console and the "motor disconnected" alarm recurred.While attempting to diagnose issue, a burning smell was reportedly detected to be coming from one of the set-ups.Both motors were on arm brackets and the consoles were reportedly well ventilated on the cart.Motor was reportedly making a faint pulsing alarm sound when plugged into the primary console.Additional information indicates that the patient was going to be weaned from support and when the hospital staff couldn't get the primary consoles restarted, they clamped the patient off of support and the patient did fine.No harm to the patient was reported during this event.

Manufacturer Narrative

Usage of the device: the usage of the motor is not known to the manufacturer as the device is not labeled for single use.The reported event of a motor disconnected alarm status as well as a burning scent was confirmed during the analysis of the returned motor.The housing at the motor-lemo connection was opened and breakdown was confirmed that resulted in a short to ground via the shield, which has the potential to result in printed circuit board (pcb) damage that was confirmed in the returned primary console (reference the manufacturer's medwatch #2916596-2013-01339 for the centrimag primary console).The motor was determined to be the root cause of the reported event.The motor was manufactured prior to the implementation of the manufacturer's corrective action that addresses this type of breakdown.The manufacturing process of the motor was adjusted to reduce the likelihood of the mesh wires damaging the motor signal wire.A review of the device history records showed no deviations from manufacturing or qa specification.No further information is available.The manufacturing is closing its file on this event.

• Brand Name: THORATEC CENTRIMAG MOTOR
• Type of Device: DWA: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; zurich CH-8 005; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-8 005; SZ CH-8005
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 7812720139
• MDR Report Key: 3865198
• MDR Text Key: 16596072
• Report Number: 2916596-2014-00156
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• 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
• Date Returned to Manufacturer: 09/20/2013
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2013
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2014
• Date Manufacturer Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other