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

Model Number 102956

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2022

Event Type  malfunction  

Manufacturer Narrative

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 centrimag motor had issues with centering the rotor.The motor would not connect properly to the centrimag console.Additional information was received that the cause of the issue was not identified and the issue did not resolve.The motor was removed from use and returned for analysis.There were no patient consequences.Related mfr.Report number: 3003306248-2022-00042.

Manufacturer Narrative

G2: health professional was selected inadvertently.Manufacturer's investigation conclusion: the reported event of the motor not connecting properly to the console was confirmed.The centrimag motor was returned for analysis to the european distribution center (edc).When connected to a test system a ¿motor disconnected: m2¿ alarm was active.The motor cable was tested, and an open lead was found.The value did not fluctuate when the motor cable was manipulated.The motor was scrapped; however, the customer requested the motor be sent back.The root cause for the reported event was conclusively determined to be wire fatigue within the cable.The device history records were reviewed for the centrimag motor and the motor was found to pass all manufacturing and qa specifications.Centrimag motor instructions for use instructs to always have a back-up centrimag motor available.Centrimag blood pump instructions for use states "always have a spare centrimag blood pump, back-up console and equipment available for change out." centrimag primary console operating manual 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, OUS
• 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: 13759776
• MDR Text Key: 287709797
• Report Number: 3003306248-2022-00041
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 7640135140078
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/14/2022
• Supplement Dates Manufacturer Received: 03/30/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: FA-Q318-MCS-1
• Patient Sequence Number: 1