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

Model Number 102956

Device Problem Overheating of Device (1437)

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

Event Date 04/28/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned for investigation.The evaluation is not yet complete.Approximate age of device ¿ the motor is not a single use device.The approximate age of the device is calculated from the manufacture date.It will be added when the manufacturer¿s investigation is completed.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was being supported with a ventricular assist device for acute support.It was reported that the extracorporeal membrane oxygenation (ecmo) alarmed with ¿m6 motor overheated¿ alarm.Customer had to do a motor change to the backup console.The rpms were at like 5300 and the flows were about 5.9 to 6 lpm which was customer thought it overheated.The motor they changed it to was already getting warm so they may or may not have to do another motor change.The customer took another console and motor arm up there from the pump room for their new backup.Per customer, the family met regarding this patient's prognosis and made the patient a do-not-resuscitate (dnr).No cause identified for the m6 alarm.Patient was following at high speeds, but did not have this issue before.Extremely warm motor when touched.Care was withdrawn, but unrelated to this event.

Manufacturer Narrative

Section g1: correction.Section h3, h4: additional information.Manufacturer's investigation conclusion: the reported event of a motor over temp: m6 alarm was confirmed via the log file in the console investigation, mfr#2916596-2019-02750.The centrimag motor (serial #: (b)(6)) was returned for analysis.The motor cable underwent resistance and insulation testing and passed.The motor was forwarded to the service depot for analysis.The returned motor was evaluated and tested.The service depot was unable to verify or duplicate the reported event of a m6 alarm.The motor was run for an extended period of time, including overnight, with the returned and associated console (serial #: (b)(6)) and flow probe (serial #: (b)(6)).No m6 alarms or any other error messages were active at any point.The motor was run at every specified rpm and flow speeds to check for signs of the motor overheating.The motor remained at normal temperatures at all times.The motor performed as intended.A full functional checkout was performed, and the unit passed all tests.The root cause for the motor over temp: m6 alarm was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• 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
• MDR Report Key: 8724545
• MDR Text Key: 148914561
• Report Number: 2916596-2019-02968
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 7640135140078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 06/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 105