MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR

Catalog Number 201-10002

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 10/24/2015

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth at time of event; sex; weight were not provided.Additionally, the event occurred during preparation and the device was not in use on the patient.Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.The motor is not a single use device.Approximate age of the device is 6 years, 10 months calculated from the ship date of the motor.The device is expected to be returned for evaluation.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

It was reported that on (b)(6) 2015, extracorporeal membrane oxygenation (ecmo) support was to be initiated for a patient in critical condition due to cardiogenic shock.A technician was called to the operating theatre to set up the extracorporeal circulatory support pump system.Reportedly, the pump circuit was properly primed, prepped and installed into the motor; however, when the console was powered on before the patient was placed on the pump, a motor stop alarm occurred.The technician repeatedly disconnected and reconnected the motor cable and tapped the motor, however the attempts to start the motor were not successful.The technician replaced the motor and the ecmo support was successfully initiated.The length of the time delay before the ecmo support was initiated was not provided.The patient reportedly expired on an unspecified later date due to cardiogenic shock.The day following initiation of the ecmo support, the technician reportedly connected the suspect motor to another console and no alarms were reported.No further information was provided.

Manufacturer Narrative

Device analysis: the motor was returned for analysis and the report of a ¿motor stopped¿ alert was unable to be reproduced during the investigation.Full functional testing of the returned motor was performed using laboratory equipment.The motor operated as expected during the testing and at no time did a ¿motor stopped¿ alert or motor stoppage occur.As per the design of the system, the console alerts ¿motor stopped¿ when the pump is inserted incorrectly during the start-up phase.This alert message can only be cleared by powering the console off and on again, when the pump is inserted correctly.During the testing, the reported alarm could only be triggered by inserting the pump improperly during the start-up phase of the console software, which is as expected.The returned motor functioned as intended during analysis.A cause of the ¿motor stopped¿ alarm was unable to be determined.A review of the device history record revealed no deviations from manufacturing or quality assurance specifications.No further information is available.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG MOTOR
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zürich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 5291896
• MDR Text Key: 33962404
• Report Number: 2916596-2015-02355
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201-10002
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2008
• 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