MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Model Number 102956

Device Problems Loss of Power (1475); Pumping Stopped (1503)

Patient Problem Death (1802)

Event Date 12/13/2016

Event Type  Injury  

Manufacturer Narrative

This event is related to another complaint which is reported under mfr report # 2916596-2017-00058.Approximate age of device- 10 years, 2 months.Manufacturer's investigation conclusion: the reported event could not be confirmed nor reproduced during testing of the returned centrimag motor.The returned motor was evaluated and tested by tech service.The reported complaint was not verified nor reproduced during testing of the returned motor.The motor was operated for an extended period of time but it did not overheat at any point nor did it activate any alarms or error messages.As an added observation, the motor's set screw was found to be broken.The damaged locking feature was replaced with a new one.This issue could not be correlated to the reported event.The motor's cable was inspected and no issues were observed.The motor was functionally tested per the centrimag motor service process and the unit passed all tests.The returned motor was found to function as intended.As a result, the root cause of the reported event could not be conclusively determined nor correlated to a motor related issue.The tested motor was returned to the customer site.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was supported by an extracorporeal circulatory support device.It was reported that the patient had been on extracorporeal membrane oxygenation (ecmo) for approximately 100 days.The patient had recently been transferred from another hospital.The patient was positive for heparin induced thrombocytopenia.During transport for a ct scan, the charge of the battery on the primary console was full per the battery fuel gauge.After 2 minutes on battery power, the system alarmed "battery below minimum".It was reported that there was zero flow and pump stoppage occurred; however, the battery display still read full charge.The patient was gray in color, and chest compressions were performed for approximately 1 minute.It was reported that the patient was off device support for approximately 4 minutes.It was reported that the motor was very hot.The hospital clinicians changed the primary console and motor.It was reported that the device functions as expected after the equipment was exchanged, and the patient was back to baseline after the event.The patient expired a few days later after the family electively withdrew care.The vad team does not believe the incident led to the patient¿s death.No additional information was provided.A user facility medwatch report was received subsequent to the initial manufacturer medwatch submission which stated: pt was being transported while on centrimag ecmo.Machine was using its battery life.Pump stopped forward flow and alarmed "battery below minimum", though the indicator displayed a full charge battery.Drive head was switched out and placed on back-up battery.Cpr was initiated for pt and flow restored.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8607899
• MDR Text Key: 144971015
• Report Number: 2916596-2019-02323
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2006
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR