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

Model Number 102953

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 08/11/2022

Event Type  malfunction  

Event Description

It was reported that the pump head would not seat properly after multiple attempts.The pump was removed from circuit, a new pump head was inserted and worked properly.The pump was not on a patient at the time of the reported event.

Manufacturer Narrative

There was no patient involved in this event.The pma# provided is associated with the device's most recent approval.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the centrimag blood pump confirmed scratch marks due to abrasion of the rotor body and impeller with the pump body and rotor well, respectively.However, the evaluation was unable to confirm the report of a pump fit issue into the motor, and a specific cause for the reported pump fit issue was unable to be determined.It was reported that the centrimag blood pump was unable to properly seat in the centrimag motor after multiple attempts.The pump was removed from the motor and remounted multiple times, and the motor was changed; however, the issue was only resolved when the blood pump was replaced.The centrimag blood pump was returned with two pieces of unremarkable tubing connected to the inlet and outlet ports.No evidence of depositions or thrombus formations was found throughout the returned tubing or pump.Examination of the pump¿s inlet and outlet ports revealed no evidence of cracking or other damage.Some small concentric marks in the bottom pump housing were noted.No abnormal impressions were observed next to the four grooves on the periphery of the blood pump.The rotor well showed some scratches that appeared vertical as well as concentric under a microscope.There was no evidence of separation or slippage between the rotor magnet and rotor body.Scratch marks were confirmed in the clear bottom of the pump housing and in the clear rotor well.The scratch marks in the bottom of the pump housing appeared concentric and due to abrasion with the bottom of the rotor impeller.The scratch marks in the rotor well appeared vertical and concentric due to abrasion with the rotor body.The scratch marks could have occurred as a result of the report of the rotor vibrating due to an improperly seated pump.However, the returned blood pump was able to be seated properly into a test motor upon return and no rotor vibration issues were noted during hydraulic qualification testing.The blood pump was functionally tested on a mock circulatory loop with a test motor and equipment as no other equipment was returned.The blood pump functioned as intended in accordance with manufacturing specification.Review of the device history record (dhr) for the centrimag blood pump revealed no deviations from manufacturing or quality assurance specifications.The us centrimag blood pump instructions for use (ifu) is currently available and provides the following warnings and cautions: ifu caution #8: ensure the pump is properly locked into the motor per the instructions for use supplied with the motor.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.The section titled ¿pump setup and operation¿ provides instructions for how to mount the blood pump on the motor.The following instructions are provided: to mount the pump on the motor, remove the pump from the inner tray and insert the pump into the motor receptacle.Place the bottom of the pump into the motor receptacle with the outlet port positioned in the large groove.Match the grooves on the periphery of the pump with the fittings on the motor receptacle.Rotate the pump counterclockwise until the pump locks securely into place.Thread the retaining screw clockwise to secure in place.The pump must be fully seated into the receptacle to function properly.The section titled ¿emergency backup equipment¿ states that a backup sterile pump and supplies to prime must be available.The 2nd generation centrimag system operating manual section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, 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 main console, motor or flow probe experience a malfunction." no further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that when the pump head was mounted, the rotor of the blood pump "did a little dance" when started with a lot of rotor vibration.

• Brand Name: CENTRIMAG BLOOD PUMP
• 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: 15365637
• MDR Text Key: 304024119
• Report Number: 3003306248-2022-12497
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 7640135140627
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102953
• Device Lot Number: L06986-LA7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• 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