MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG PRIMARY CONSOLE; 2ND GENERATION CENTRIMAG PRIMARY CONSOLE

Catalog Number 201-30300

Device Problem Failure to Pump (1502)

Patient Problems Bradycardia (1751); Death (1802); Hypoxia (1918)

Event Date 01/17/2016

Event Type  Death  

Manufacturer Narrative

Age/date of birth at time of event; weight were not provided.Information received referred to the patient as a "kid".Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.The primary console is not a single use device.Approximate age of the device is 3 years and 8 months (calculated from the ship date of the primary console).The device has been returned for investigation.The evaluation is not yet complete.The event occurred at hospital (b)(6).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

It was reported that the pediatric patient was placed on an extracorporeal circulatory support device to implement extracorporeal membrane oxygenation (ecmo) for severe acute respiratory distress syndrome.It was reported that the patient was immunocompromised prior to the procedure.The patient was cannulated via unspecified vessels in the neck without issue.After connecting the ecmo circuit it was reported that a blood flow of -250 milliliters per minute of desaturated arterial blood was detected, and that the pump was not rotating.The negative blood flow reading did not increase despite attempts to increase the revolutions per minute of the pump.The resistance in the circuit became higher than the patient¿s blood pressure causing a reduction in flow.Due to lack of flow and low pressure in the venous line the blood became bright red from the diffusion of gases and oxygen from the oxygenator.The cannulae were repositioned under ultrasound and the ecmo circuit was replaced without any improvement.The patient desaturated and became bradycardic requiring multiple doses of adrenaline.The thorax was opened emergently and central cannulation of the ecmo circuit was performed.Another attempt was made to initiate ecmo support, and it was reported that the same scenario as described above occurred.The console in use was then power cycled and began to function as expected.It was reported that the event had relevant clinical consequences since the patient needed to be ¿reanimated¿ due to the delay in the initiation of ecmo support.The patient expired four days after the event due to sepsis that ultimately prevented the use of ecmo support.

Manufacturer Narrative

The returned console and motor operated as intended throughout their analysis.The reported event could not be confirmed and no fault was found with the returned devices.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG PRIMARY CONSOLE
• Type of Device: 2ND GENERATION CENTRIMAG PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; ch-8005 zurich ; SZ
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zürich CA CH-80 05; SZ CH-8005
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 5499609
• MDR Text Key: 40299006
• Report Number: 2916596-2016-00462
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 201-30300
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2012
• 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): Death; Life Threatening