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

Catalog Number L102954

Device Problems Pumping Stopped (1503); Infusion or Flow Problem (2964)

Patient Problem Loss of consciousness (2418)

Event Date 07/14/2016

Event Type  Injury  

Manufacturer Narrative

This report is regarding the primary console in use on the patient at the time of the interruption in support.Reference mfr report # 2916596-2016-01533 for the report on the backup console and mfr report # 2916596-2016-01534 for the report on the blood pump.Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Concomitant medical products - backup console, sn (b)(4) and blood pump.The primary console is not a single use device.Approximate age of the device is 8 years (calculated from the manufacture date of the primary console).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

The patient was placed on an extracorporeal circulatory support device for extracorporeal membrane oxygenation on (b)(6) 2016.On (b)(6) 2016, the patient was transported to ct scan and during the scan, it was noted that no flow was registered on the console and a low flow alarm sounded.The nurse cleaned the flow probe and repositioned it without success.The surgeon was notified that the console had shut off.The nurse tried to exchange to the backup console and that too would not "work".There was no flow despite increasing the rpms.Subsequently, the circuit was found to be clotted and needed to be exchanged.It was reported that the patient received cardiopulmonary resuscitation (cpr) for approximately 20 minutes while the circuit and console were exchanged.It was thought that the circuit clotted because the motor stopped.A new blood pump was brought from the icu and after the circuit was changed, patient support was restored and flow resumed.When the exchanged circuit was returned from ct scan, the devices reportedly functioned as intended when tested by the hospital staff.The patient remained on support on the third console and the motor.The customer planned to keep the motor in use, as it was supporting the pump without issue.After cpr was administered, the patient awoke and regained all neurological function.The event was considered resolved with no adverse sequela.It was reported that the patient experienced an anoxic event on (b)(6) 2016.The healthcare professionals declined to provide further information regarding the death; however, the anoxic event and subsequent patient outcome was reported as not associated with the extracorporeal circulatory support system or the previous event.

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The report of a blood clot in the blood pump could not be confirmed nor correlated to a device related issue.Thromboembolic phenomena is listed in the instructions for use as a potential adverse event that may be associated with the use of the centrimag blood pump and warns the user to monitor the circuit carefully for any signs of occlusion.A review of the device history records could not be performed as the device lot number was not provided.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG PRIMARY CONSOLE
• Type of Device: CENTRIMAG PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; ch-8005 zurich ; SZ
• 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: 5870422
• MDR Text Key: 51923282
• Report Number: 2916596-2016-01532
• 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: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: L102954
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2016
• Initial Date FDA Received: 08/11/2016
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2008
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 18 YR
• Patient Weight: 47