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

Model Number 102956

Device Problems Pumping Stopped (1503); Vibration (1674); Noise, Audible (3273)

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

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier, sex: the patient initial and gender was not provided.Description of problem or event: this is reported again the cmag motor.The console is reported under mfr report # 2916596-2019-02312.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that patient was on centrimag (cmag) support during a surgical procedure that was unrelated to the patient being placed on cmag.Towards the end of the procedure, a humming and clicking noise was heard coming from the cmag motor.The clinical team observed the rpms drop from 4300 to 3250 and the flow waveform on the cmag monitor dropped to 0 sounding an alarm.The system was stopped.The cmag system was replaced with a backup and the system was initiated again.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a drop in speed and flow, a flow below minimum alarm, and a clicking sound coming from the motor was not confirmed.The centrimag motor was returned for analysis.The motor underwent resistance and insulation testing and passed.The returned motor was forwarded to the service depot.The motor was evaluated and tested under work order # (b)(4).The service depot was unable to verify or duplicate the reported event of a clicking noise from the motor, a speed and flow drop, and a flow below minimum alarm.The motor was tested for an extended period of time with the returned and associated console, flow probe, and monitor.No alarms or issues occurred with the flow.No faults were found, and the motor performed as intended.Per field action ¿fa-q318-mcs-1¿, the motor¿s cable was inspected for breakdown and no issues were found.Reports of similar events will continue to be tracked and monitored.The root cause for the reported event of a clicking noise from the motor, a speed and flow drop, and a flow below minimum alarm was not conclusively determined through this analysis.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: 8647205
• MDR Text Key: 146274509
• Report Number: 2916596-2019-02311
• 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
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2019
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 150