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

Model Number 102956

Device Problems Overheating of Device (1437); Noise, Audible (3273)

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

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: the product information and disposition of the centrimag blood pump and primary console was not provided but will be requested.The motor is not a single use device.Approximate age of the device is not known at this time as the manufacture date of the motor is not available.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was placed on biventricular extracorporeal circulatory support at an unspecified date.It was reported that the system indicated a system alert (s3) and a set pump speed not reached alert (m5).The pump had no flow during this period.Upon exchanging the motor and console, the motor begun making a loud ¿whirring¿ noise and was very hot to touch.The motor was properly seeded but had no resolution to the issue therefore the device was switched out again.The patient remained stable during the event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported s3 and m5 alerts associated with flow readings of 0 lpm were confirmed through the evaluation of the log file data downloaded from the returned centrimag 2nd generation primary console; however, no device-related issues were discovered during the evaluation of the returned centrimag motor and a specific cause for the reported event could not be conclusively determined through the investigation of the returned device.The reported event of the motor making an odd noise and feeling hot could not be confirmed during the investigation.It was reported that the centrimag system produced s3 (system alert) and m5 (set pump speed not reached) errors while supporting a patient.At the time the alerts were active, there was reportedly no flow displayed.The motor was reportedly making a loud ¿whirring¿ noise and was very hot to the touch.An exchange was made to a new console and motor and the alarms subsequently resolved.The log file retrieved from the 2nd generation primary console contained data from the time of the reported event from (b)(6) 2018 ¿ (b)(6) 2018, according to the timestamp.At the time of the reported event, the console was operating a motor at approximately 4400 rpm with a flow of approximately 6 lpm.On (b)(6) 2018 at 7:12 pm, the log file captured an active s3 (system alert) alert followed by a reduction in pump speed to approximately 3200 rpm and an active m5 (pump speed not reached) alert.During this event, the flow reading reduced to 0 lpm.Pump speed remained at approximately 3400 rpm with a flow reading of 0 lpm until the motor was disconnected and the pump was removed from the system at 7:17 pm.During the s3 and m5 alerts, no full pump stoppage events occurred.The console continued to support the system but at a reduced speed of approximately 3200-3400 rpm.Of note, no m6 (motor over temp) alerts were captured.The returned centrimag motor was evaluated by abbott technical services personnel under work order (b)(4).The reported complaint was not confirmed.The returned motor was ran for an extended period of time and was checked at every specified pump speed and flow value for any odd or abnormal noise coming from the device.No odd noises were reproduced.The motor cable was inspected for any issues that might trigger noises or alarms and no issues were found with the cable.A full functional checkout was performed and the unit passed all tests.The returned device was found to function as intended and the root cause for the reported event could not be conclusively determined.The centrimag motor was returned to the customer site.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: 8139608
• MDR Text Key: 130040857
• Report Number: 2916596-2018-05495
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

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: Lay User/Patient
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 03/22/2019
• Supplement Dates FDA Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG BLOOD PUMP; CENTRIMAG PRIMARY CONSOLE