MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR; CARDIOPULMONARY BYPASS PUMP SPEED CONTROL

Catalog Number 102956

Device Problems Smoking (1585); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

It was reported that a "pop" was heard from the device and there appeared to be smoke.The device was not in use on a patient at the time of the event.No additional information was received.

Manufacturer Narrative

There was no patient involvement.Approximate age of device - 6 years and 5 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 device analysis is completed.Placeholder.

Manufacturer Narrative

During a retrospective review of the complaint file, it was noted that this event was inadvertently submitted.The devices were not in use on a patient and there would be no adverse impact to the hospital personnel testing the device.The device was taken out of service.Although this is deemed not a reportable event, the investigation results are provided below.The motor and console are not single use devices.Approximate age of the motor - 1 year and 2 months (calculated from the ship date of the motor); approximate age of the console - 5 years and 5 months (calculated from the ship date of the console).Device evaluation: the returned console¿s housing was opened for visual inspection of the internal printed circuit boards (pcb) which revealed that one power switch was damaged which resulted in damage to a fuse on the console¿s main printed circuit board.Evaluation and functional testing of the returned motor (part number: 102956; serial # (b)(4)) found that bending of the motor cable in the middle section resulted in an intermittent short circuit to the outer cable shield.Based on the investigation findings, the cause of the damaged console power switch was a temporary short circuit inside the cable of the associated motor.The point in time when the short circuit occurred could not be conclusively determined.A specific cause for the cable damage could not be conclusively determined.A review of the device history records of the console and motor revealed no deviations from manufacturing or quality assurance specifications.No further information is available.The manufacturer is closing its file on this event.

• Brand Name: THORATEC CENTRIMAG MOTOR
• Type of Device: CARDIOPULMONARY BYPASS PUMP SPEED CONTROL
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zürich CA CH-80 05; SZ CH-8005
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564071
• MDR Report Key: 4747077
• MDR Text Key: 5709459
• Report Number: 2916596-2015-00804
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102956
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1