MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problems No Display/Image (1183); Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2019

Event Type  Injury  

Manufacturer Narrative

This report addresses the console.The motor is reported under mfr.#2916596-2020-00796.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that while the patient was on extracorporeal membrane oxygenation (ecmo) support, the motor became noisy and very warm, and a burning smell was noted.As the healthcare provider was powering up the backup console, the console in use went blank (no lights or power) and the motor stopped.The motor was exchanged.Ecmo support was discontinued on (b)(6) 2019.The event was reported to have been resolved.

Event Description

Related manufacturer report number: (b)(4).

Manufacturer Narrative

Section d4: correction.Section b5, d10, d11, g5, h3, h4, h7, h9: additional information.Manufacturer's investigation conclusions: the reported event of the console going blank was confirmed via the log file.The centrimag motor (serial #: (b)(6)) was returned to analysis and a log file was downloaded from the returned and associated centrimag 2nd generation primary console.A review of the downloaded log file showed events spanning approximately 133 days ((b)(6)2019 ¿ (b)(6)2020 per time stamp).On (b)(6)2019 at 03:29:00, the sub fault ifd_shutdown_detected activated and triggered a ¿system alert: s3¿ and ¿set pump speed not reached: m5¿ activated.The motor speed dropped to ~3300 rpm and the flow dropped to 0 lpm.The motor speed recovered, and the pump was removed from the motor at 03:30:00.There were no other notable alarms active in the log file.The centrimag motor (serial #: (b)(6)) was evaluated and tested.The motor was determined to be the root cause of the reported event.Reports of similar events have been documented and corrective action had been initiated to investigate the issue further.The investigation has determined that this event was caused by a motor related issue.Final disposition of the motors will be determined by the capa.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.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9703492
• MDR Text Key: 180768757
• Report Number: 2916596-2020-00795
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1
• Treatment: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE.