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

Model Number 102956

Device Problem Overheating of Device (1437)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/30/2022

Event Type  Injury  

Manufacturer Narrative

Patient information was requested but not yet provided.Serial number was requested but not yet provided.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient was on support for extra corporeal membrane oxygenation.The most recent circuit change was approximately 17 days prior to the event.The patient had been off of anticoagulation throughout ecmo course due to bleeding.The patient was not on heparin drip.On (b)(6) 2022 the patient was at 1100 and the motor was reported to be hot to the touch with no alarms.The team switched to full backup battery system.On (b)(6) 2022 the motor was still hot but as not as hot as the previous.A plan was made to not switch anything and to continue to monitor the patient.A large circuit change was considered but the patient was dependent on ecmo.Rotations per minute were at 5300 on the current system and the previous one switched out.Speeds on 5500 rpm were unable to be obtained.The motor would be returned for evaluation.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the motor overheating and not reaching 5500 rpms was not confirmed.The centrimag motor serial #: (b)(4) was not returned for analysis.Multiple good faith efforts were sent to retrieve additional information including the serial number of the centrimag 1st generation primary console and if anything would be returning for evaluation; however, no response was received.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for the centrimag motor serial #: (b)(4) and the motor was found to pass all manufacturing and qa specifications.Centrimag motor instructions for use (rev.G) instructs to always have a back-up centrimag motor available.Centrimag blood pump instructions for use (rev.E) states "always have a spare centrimag blood pump, back-up console and equipment available for change out." centrimag primary console operating manual (rev.I) warns "one back-up console and motor are required in the immediate vicinity of each patient whenever the centrimag blood pump is used.The back-up console must be connected to the back-up motor, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the primary console or primary motor experience a malfunction." 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
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 13506190
• MDR Text Key: 289487392
• Report Number: 3003306248-2022-00014
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization