MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG PRIMARY CONSOLE

Catalog Number 201-90411

Device Problem Device Stops Intermittently (1599)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Information (3190)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

The patient's age, sex and weight were not provided.(b)(4).Approximate age of device - the centrimag primary console is not a single use device.The approximate age of the device from the date of manufacture is 7 months.The device was returned for investigation.The evaluation is not yet complete.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was implanted with an extracorporeal circulatory support device.It was reported that the patient had been placed on extracorporeal membrane oxygenation support (ecmo) and was being transported from the intensive care unit to the operating room (or) for a ventricular assist device implant.During transport, the clinician hit a "bump" in the hallway with the transport cart, causing the monitor to flicker and the screen to go black.The console then went completely blue on the front screen and pump stoppage occurred.Mean arterial pressure (map) dropped to 45-50 mmhg, and the anesthesiologist administered inotropes.The blood circuit tubing was clamped, and the motor cord was switched from the primary console to the backup console.The pump restarted with flows visible on the monitor, and the patient appeared clinically stable after the pump restarted.The system was exchanged over to a new primary console in the operating room.The vad implant proceeded as planned.It was reported that the patient experienced unspecified symptoms associated with the pump stoppage.No additional information was provided.

Manufacturer Narrative

Serial # (b)(4); unique identifier (udi) # (device identifier): (b)(4).The user facility report # (b)(4).Device evaluation: the console, mag monitor and motor involved in the reported event were returned for evaluation.Full functional testing of the returned devices was performed using laboratory equipment.The console, mag monitor and motor operated as expected during the testing and at no time did the monitor to flicker or screen to go black or a motor stoppage occur.Long runtime, interference (electromagnetic fields) from outside and vibrations during operation testing didn't trigger any failure on the returned systems and the incident was not reproduced.Following an onsite visit by the manufacturer¿s representatives, it was determined that the customer had used a custom-made (non-manufacturer) cart and conductive metal fixtures to mount the console units and attach the monitor.These were noticed to be different from the non-conductive standoff fixtures supplied with the console.The motor-stop and system-restart events were able to be reproduced with electrostatic discharge events in combination with an incorrect installation of the centrimag system.When the non-conforming, custom-made fixtures (metallic poles from the customer) were used to affix the consoles to the cart in order to perform the esd immunity testing, events of motor-stops and the console-displays¿ resetting were noted.These results revealed that the use of the custom-made fixtures did not comply with the iec 61000-4-2:2008 standards.During the investigation, the reported and observed motor stop and system restart events were reproduced under electrostatic discharge conditions when the customer¿s custom conductive standoff was used.If the system was setup per the instructions for use and conforming manufacturer¿s accessories were used, the esd events triggering system failures were not reproduced.The root cause of the reported event was therefore determined to be the use of the custom conductive fixtures.The customer was informed to discontinue future use of these custom fixtures.Review of the device history records for the returned devices (console, mag monitor and motor) showed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.

Event Description

A user facility report (uf report# (b)(4)) for this event was received on (b)(6) 2017 stating: event desc: patient on extracorporeal membrane oxygenation (ecmo) support via centrimag generation 2, was being transported via bed to the or.Reportedly, during transport the bed went over a bump, and the centrimag generation 2 monitor went blank, and the pump stopped.Reportedly, patient became hypotensive and required administration of medication.Pump was switched to the back-up unit after which flows returned, hemodynamics returned to baseline, and patient was taken to the or.No reported patient harm.What was the original intended procedure? ecmo.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: THORATEC CENTRIMAG PRIMARY CONSOLE
• Type of Device: CENTRIMAG PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich 8005 ; SZ 8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6560642
• MDR Text Key: 75151080
• Report Number: 2916596-2017-00973
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 201-90411
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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
• Treatment: CMAG MONITOR/SN (B)(4),MOTOR/(B)(4)