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

Catalog Number 102956

Device Problems Overheating of Device (1437); Infusion or Flow Problem (2964)

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

Event Date 11/10/2018

Event Type  Injury  

Manufacturer Narrative

This medwatch is reporting the motor.The console is reported under medwatch mfr report #2916596-2018-05347 the centrimag motor is not a single use device.Approximate age of the device is unknown.The device was returned for investigation.The evaluation is not yet complete.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was started on extracorporeal circulatory support on an unspecified date.It was reported that an m5 and s3 alarm was received on the centrimag (cmag) console.The cmag console was reported to be extremely hot to the touch and went completely blank.Despite the alarms and hot cmag console, the cmag motor continued to run and the monitor remained on.It was reported that flow could not be read as both the cmag console and monitor were reflecting only dashes.In addition, the motor speed could not be changed.Due to the event, the cmag console and cmag motor were exchanged and the issue resolved.Additional information was requested, but not yet provided.

Manufacturer Narrative

Device evaluation: the reported events could not be confirmed nor reproduced during testing of the returned centrimag motor (serial number (b)(4)).The motor was evaluated and tested by tech service under work order #(b)(4).The reported issue could not be confirmed during their testing and the issue could not be confirmed.The returned motor was tested for an extended period of time with its related centrimag 2nd gen primary console (serial number (b)(4), evaluated under pi-2018-0208568-02) and flow probe (serial number (b)(4), evaluated under pi-2018-0208568-03) returned for this complaint.No atypical alarms or events were reproduced during testing.The motor was operated at different speed settings without any issues being reproduced.No atypical temperature elevations were reproduced during testing.Inspection of the motor's cable did not reveal any issues.Full functional checkout was performed per the centrimag motor service process and the motor 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.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: patient was started on cmag on (b)(6) 2018.Patient did not undergo any additional treatment.Patient was stable during the motor and console exchange.Patient was weaned from ecmo and is doing well at home.

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: 8113396
• MDR Text Key: 128717406
• Report Number: 2916596-2018-05346
• 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
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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
• Initial Date Manufacturer Received: 11/11/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 11/11/2018; 08/08/2019
• Supplement Dates FDA Received: 03/08/2019; 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 93