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

Catalog Number 201-30100

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 05/19/2017

Event Type  Injury  

Manufacturer Narrative

The primary console is not a single use device.Approximate age of the device is 7 years, 9 months (calculated from the manufacture date of the primary console).The device is expected to be returned for analysis.It has not yet been received.The event occurred at (b)(6).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was placed on extracorporeal circulatory support on (b)(6) 2017.It was reported that the primary console alarmed "battery charge fail" and a smell of burnt plastic was noticed.There was no reported interruption in circulatory support.The patient was immediately switched to the backup primary console without issue.Reportedly, the patient was not harmed or injured due to the event.The distributor's engineering representative reported that the primary console powered up correctly, but the internal fan was not rotating.The primary console was opened and it was discovered that one of the stick-on cable management plastic clips that holds one of the ribbon cables in place had fallen off the inside of the casing and had become trapped in the fan housing, stalling the fan's blades.No additional information was provided.

Manufacturer Narrative

Device evaluation: the report of a plastic cable holder inside the primary console was confirmed through a visual inspection of the device.The plastic cable holder was found lying inside the console near the fan.Although the cable holder would not have damaged the fan, the cable holder could have blocked the fan from rotating and caused the internal temperature of the console to increase.The reported ¿battery charge fail¿ alert would have occurred as a results of the internal temperature exceeding the specified limit if the console was charging its internal battery pack.The returned primary console was visually inspected and no burn marks or defective parts were found.The returned console was functionally tested while connected to an in-house motor and flow probe, attached to a test loop, and no fault occurred.The reported battery charge fail alert could not be reproduced and the system always operated as intended.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; zürich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; technoparkstrasse 1; pleasanton CA 94588
• Manufacturer Contact: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 6679159
• MDR Text Key: 78761628
• Report Number: 2916596-2017-01384
• Device Sequence Number: 1
• Product Code: DWA
• 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: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201-30100
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2009
• 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): Required Intervention
• Patient Age: 35 YR