MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR; MOTOR, RENTAL

Model Number L102956

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

No patient involved so patient information was provided.Approximate age of device ¿ 9 months 19 days.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that a loaner centrimag motor overheated while in use.No alarm went off and the pump never stopped, but the health care provider who experienced the issue said the motor felt very hot to the touch so they did a motor change out just to be safe.According to the health care provider there were no visible clots in the circuit.No additional information was reported.

Manufacturer Narrative

Patient identifier, sex, weight: additional information.Device available for evaluation and device evaluated by mfr: corrected data.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of an overheating centrimag motor could not be confirmed nor reproduced during the investigation.The returned centrimag motor (serial number (b)(4) was evaluated and tested by the service depot under work order #53733276.The motor was left running for 6 hours alongside another motor to see if there were any temperature differences.After checking the temperature on both motors, the suspected motor ran a couple degrees cooler than the other motor.Also, both motors did not have any alarms of overheating during the comparison.The motor was tested per the centrimag motor service process (doc.#1004577, rev.G) and the unit passed all tests.The motor performed without any issues and passed all required tests.The old motor ifu was replaced with a new revised pl-0069, rev.4 motor ifu as a corrective action for field action fa-q318-mcs-1.The tested motor was returned to the rental pool.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.

Manufacturer Narrative

Section device manufacture date: corrected data.

• Brand Name: CENTRIMAG MOTOR
• Type of Device: MOTOR, RENTAL
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8452004
• MDR Text Key: 139856298
• Report Number: 3003306248-2019-00001
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• 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,Followup,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L102956
• Device Catalogue Number: L102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 06/28/2019; 07/22/2019; 08/14/2019
• Supplement Dates FDA Received: 07/21/2019; 07/23/2019; 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 65