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 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

The motor is not a single use device.The device is expected to be returned for evaluation.It has not yet been received.Additional information was requested but has not been received.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was supported by an extracorporeal circulatory support device.It was reported that the primary console and monitor were reflecting only dashes on the screen, but everything else was functioning.The nurse thought the motor felt warm and heard noises coming from the pump head.The flow probe was exchanged but the system was still only indicating dashes for flow.The primary console and motor were exchanged.As the pump was being switched to the backup, it was noted that the console and monitor went blank.Once the exchange was completed, support was immediately restored.There was no adverse effects to the patient due to this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of flow blanking and high motor temperatures could not be confirmed nor reproduced during testing of the returned centrimag motor.The motor was evaluated and tested and the reported complaint was not verified during testing.The motor was operated with its related system equipment for an extended period of time without any atypical alarms or events being reproduced.The system was operated at various speeds and no flow issues, events, or alarms were reproduced.No abnormal noise was obsrved and no atypical motor temperatures were observed during testing.The motor's cable was inspected and no issues were observed.Full functional checkout was performed 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.The tested unit was returned to the customer site.Reports of similar events will continue to be tracked and monitored.A review of the device history records revealed the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

The device returned for analysis.The complaint investigation determined the reported difficulty was the result of a 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: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8104309
• MDR Text Key: 128390935
• Report Number: 2916596-2018-05120
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• 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: 11/19/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1
• Treatment: PRIMARY CONSOLE, L06340-0008