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

Model Number 102964

Device Problem Decreased Pump Speed (1500)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided.The motor is a single use device.The approximate age of the device could not be determined as the serial number was not provided.Manufacturer's investigation conclusion: the motor was not returned to the manufacturer for analysis.Review of the log file retrieved from the returned primary console (console) confirmed the reported system alert (s3 alarm).The analysis of the log file data revealed that the console was supporting a pump for multiple days prior to the reported event occurring.The system was operated at 3700 rpm with flow in the 4.4-5 lpm range.At approximately 4:22 am on (b)(6) 2017 the log captured an active "system alert: s3" alarm, consistent with the reported information.This event was followed by a drop in pump speed to 2800 rpm.The exact flow value at the time could not be conclusively determined due to a flow board error, which requires the console to be power-cycled.These events were followed by an active "motor alarm: m4".These alarms were muted but not cleared.Around approximately 4:25 am the speed was logged being only approximately 2900 rpm.Then, the user set the speed to 3800 rpm and back to 3700 rpm.However, the motor did not reach the set speed (it remained operating at 2900 rpm).Full functional testing of the returned console was performed using laboratory equipment.The console functioned as intended during analysis.Inspection of the internal components did not reveal any issues.Based manufacturer¿s previous complaint experience, the alarms recorded in the log file could potentially be related to an issue with the motor.The motor used at the time of the reported event was not returned for analysis and as a result, the root cause of the reported event could not be conclusively determined.A review of the device history records could not be performed as the serial number of the motor was not provided.No further information is available.The manufacturer is closing the file on this event.

Event Description

During the manufacturer's analysis of the returned primary console, a review of the log file retrieved from the device confirmed the reported system alert message which appeared related to an issue motor.The information received with the initial event indicated the devices were not in use on a patient at the time of the event.No additional information was provided.

Manufacturer Narrative

The device returned for analysis.The complaint investigation determined the reported event was the result of a software design related issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: POWER CORD
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7871804
• MDR Text Key: 120099580
• Report Number: 2916596-2018-03808
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

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: 102964
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 08/08/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1
• Treatment: (B)(4); (B)(4)