MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR

Catalog Number 102956

Device Problem Pumping Stopped (1503)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/03/2015

Event Type  malfunction  

Event Description

The patient was supported with an extracorporeal circulatory support pump.It was reported that the primary console and motor were both exchanged due to ¿the device stopping¿ while supporting the patient.It was noted that the specific alarms occurring at the time of the event were unknown.The icu personnel reported that the temperature sensor for the oxygenator alarmed ¿low temperature.¿ at that time, it was noted that the blood coming from the oxygenator was darker than usual and the primary console was reading lower flows (approximately 1 lpm).At the time of the event, the patient¿s oxygenation status decreased slightly, but she recovered very quickly after the exchange and had no lingering effects.The patient remained ongoing on the new primary console and motor.The primary console and motor were quarantined and inspected by the hospital¿s clinical engineering department and no obvious cause for the event was noted.It was mentioned that when attempting to view the primary console history, the history only showed alarms related to clinical engineering¿s testing.

Manufacturer Narrative

The patient weight was requested but was not provided.The primary console is not a single use device.The approximate age of the device from the date of manufacture is 11 months.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 completed.

Manufacturer Narrative

(b)(4).The reported event was confirmed.The returned primary console did not detect the returned motor and alarmed for motor disconnected although the motor was properly connected to the unit.However, the returned primary console operated as intended with an in-house motor.Further analysis revealed that the returned motor was defective.The root cause for the returned motor¿s defect was found to be a loose soldering connection inside the lemo-connector.A review of the device history records revealed that the devices met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC CENTRIMAG MOTOR
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; technoparkstrasse 1; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 4886038
• MDR Text Key: 6021269
• Report Number: 2916596-2015-01200
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• 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
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• 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: 07/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR