MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR

Catalog Number 201-10002

Device Problem Difficult To Position (1467)

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

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Concomitant medical products: the following devices were in use; however, it was not specified which of the products were used as the right or left support system.Information was requested but not received.Thoratec centrimag motor, serial numbers (b)(4).Thoratec 2nd generation centrimag primary consoles, serial numbers (b)(4).Flow probes, serial numbers (b)(4).Mag monitor, serial number (b)(4).The motor is not a single use device.Approximate age of the device is 1 year (b)(4) or 8 months (b)(4) calculated from the ship date of the motor.The devices have been returned for investigation.The evaluation is not yet complete.The event occurred at (b)(6).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

The patient was placed on biventricular extracorporeal circulatory support on (b)(6) 2015.On (b)(6) 2015, during a routine exchange of the pump circuits, both of the consoles displayed a ''pump not inserted'' message, although it was reported that the replacement pumps were properly inserted into the motors.Pressing the clear button reportedly did not resolve the fault message.The pump supporting the left ventricle was reinserted and flow resumed.Several unsuccessful attempts were made to seat the right ventricle replacement pump in the motor.The motor and the console were exchanged, whereupon right ventricle circulatory support was immediately restored with the same new pump and flow resumed with the spare motor and console.The patient reportedly was not symptomatic and did not experience any adverse effects due to the event.The patient remained on biventricular support until (b)(6) 2015, when support was withdrawn and the patient expired.The patient's healthcare professionals reported that there was no correlation between the event and the patient's final outcome.No further information was provided.

Manufacturer Narrative

The two primary consoles and the two motors involved in the reported event were returned for evaluation.Two flow-probes were also received.The analysis was performed with the returned motors used in the returned consoles with several test pumps and the returned flow-probes.Each system was tested ten times with three separate pumps.The returned devices all functioned as intended and passed all tests.During testing, upon removal of the pumps from the motors, it was confirmed that the systems appropriately alarmed for ¿pump not inserted¿ as expected.Upon re-seating the pumps, the alarms were successfully cleared by pressing the mute button on the consoles.The systems resumed function as expected.A ¿pump not inserted¿ alarm message is expected to occur during a pump exchange.The visual alert indicates the system will not start and is accompanied by an audible alarm.The alarms should be silenced by the mute button.If the alarm recurs after the mute button is pressed, the operator(s) should then re-insert the pump and secure it with the locking screw.Analysis of the data retrieved from both of the returned consoles revealed that the reported alarm appeared as expected.Based on the information recorded in the data logger, the operator(s) missed pressing the mute button immediately after a pump was re-inserted into the motor.The pumps were removed and re-inserted multiple times and the alarm resolved once the mute button was finally pressed.The enduring alarm might have been misinterpreted as a new alarm.A review of the device history records for all the returned equipment 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; ch-8005 zürich ; SZ
• 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: 5262645
• MDR Text Key: 32578513
• Report Number: 2916596-2015-02274
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2015

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: 11/12/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 12/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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 Age: 53 YR