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

Catalog Number 102954

Device Problems Smoking (1585); Device Stops Intermittently (1599)

Patient Problems Heart Failure (2206); Respiratory Failure (2484)

Event Date 07/08/2016

Event Type  Injury  

Manufacturer Narrative

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 5 years and 9 months (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 in conjunction with extracorporeal membrane oxygenation on (b)(6) 2016.It was reported that a short time after bedside ecmo cannulation, the bedside nurses smelled smoke, at which time the console shut down and the speed went to zero.The patient immediately decompensated with desaturation and hypotension.The nurses emergently clamped the circuit and switched to the backup console and motor.The circuit was switched to a 2nd generation circuit system.The patient immediately stabilized once flow was initiated.It was reported that no alarms were noted at the time of the incident.

Manufacturer Narrative

Device evaluation: the report of burnt smell emitting from the returned primary console was confirmed.Two printed circuit board (pcb) components were found to be defective.Based on the manufacturer¿s complaint experience, the motor was suspected to be responsible for the damaged pcbs; however, during the analysis of the suspect motor, no device related issues were detected.Therefore, the root cause could not be could not be conclusively determined.Once the damaged pcb components were replaced and the returned primary console was subjected to the reprocessing and maintenance procedure, the unit passed all tests.The returned motor remained suspect and was therefore scrapped as a precaution.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: 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: 5848082
• MDR Text Key: 51225290
• Report Number: 2916596-2016-01491
• 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: 05/01/2017

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: Lay User/Patient
• Device Catalogue Number: 102954
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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: 20 YR
• Patient Weight: 48