MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC CENTRIMAG MOTOR

Catalog Number 201-10003

Device Problems Overheating of Device (1437); Pumping Stopped (1503); Use of Device Problem (1670)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020); Cardiogenic Shock (2262)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

The patient's age, sex, and weight were not provided.Device unique identifier (udi) - device was manufactured prior to udi labeling implementation.The motor is not a single use device.The approximate age of the device from the date of manufacture is 3 years and 4 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 manufacturer¿s investigation is completed.

Event Description

The patient was supported with biventricular extracorporeal circulatory support devices.It was reported that the left ventricle pump motor overheated, causing the console to alarm on (b)(6) 2016 at approximately 10:40 pm.Flow values decreased to 0.47 lpm, the pump speed dropped to 0 rpm, the patient's mean arterial pressure decreased to 44 mmhg, and the patient complained of dizziness.The right ventricle pump flows and speed values were unchanged at this time.It was reported that the equipment was well ventilated at the time of the event and was not covered in blankets, pillows, etc.The intensive care unit staff physicians were informed immediately and arrived at the patient's bedside.The left ventricle backup console and backup motor were set up and turned on and the devices were switched out.After the switch occurred, it was reported that the flows on the both the right and left pumps became erratic with values down to 1.5-2 lpm and pump speeds between 2000-5000 rpm.The patient was reportedly ambu-bagged and started to have frothy and bloody pulmonary secretions.The patient was started on levophed, vasopressin and epinephrine for support.After a thorough investigation, it was found that the right and left consoles were switched during the equipment exchange (the right pump was at the left pump settings and vice versa).After proper speed adjustments, the flow values returned to 3-6 lpm and the patient became stable.The patient was reportedly alert and able to follow commands, but required vasopressors and additional inotropes for support.The patient was transferred to the cardiothoracic icu for close monitoring and the console and motor were returned for evaluation.No further information was provided.

Manufacturer Narrative

Device evaluation: the reported event was confirmed based on the information contained in the log file retrieved from the returned primary console.Based on the information contained in the log file and the manufacturer¿s experience from past complaint investigations, the potential root cause for the occurrence of the fault(s) was a temporary short circuit on the motor side (motor cable).The overheating of the motor was likely a secondary effect of the short circuit.Although the event could be confirmed, no fault(s) could be reproduced during the investigation.The returned primary console and motor operated as intended during the investigation.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.

Event Description

Additional information: it was reported that the returned centrimag motor may not be the same motor that was in use at the time of the event.

Manufacturer Narrative

It was reported that the hospital was uncertain of which motor was connected to the primary console at the time of the event.20 centrimag motors were returned from the hospital after the initial evaluation and additional investigation was performed.During the investigation and upon functional testing, five motors (serial numbers: (b)(4)) were found to be defective.Four of these motors exhibited intermittent breaks or shorted circuits when the motor cables were bent.The lemo connector of one motor was found to mechanically worn out and the motor generated a temporary system alert during testing.The fault did not re-occur and no cable breaks or shorted circuits were detected; however, the motor was determined to be suspect and not qualified for use in the field.The remaining fifteen motors passed functional testing and were not suspect.A review of the motors¿ device history records revealed no deviations from manufacturing or quality assurance specifications.The device history records showed that the five defective motors had been in the field for approximately 8-10 years.A root cause for the observed motor cable breaks and short circuits could not be determined, however, the age of the products and mechanical stress encountered during handling over an extended period of time could have contributed to the observed findings.Although the faults identified during log file analysis could not be reproduced, it is suspected that one of the five defective motors was in use at the time of the event and contributed to the faults.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 8005 ; SZ 8005
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: robert fryc ; 23 fourth avenue; burlington, MA 01803 ; 781272-013
• MDR Report Key: 5406092
• MDR Text Key: 37335277
• Report Number: 2916596-2016-00212
• 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,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 201-10003
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2012
• 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): Hospitalization; Required Intervention