MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH PEDIMAG BLOOD PUMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	201-90052
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient's nurse had noticed a rattling noise twice with the centrimag motor.It occurred once when the patient was agitated and once during a bath.The centrimag motor and console were exchanged to the backups.The rattling noise resolved.The units were red tagged and removed from clinical use.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: review of the submitted video confirmed the reported noise from an operating pump and motor; however, a specific cause for this finding could not be conclusively determined through this evaluation.The patient¿s nurse noticed a rattling noise on (b)(6) 2025 when the patient was agitated and during a bath.The pump speed was 3200 revolutions per minute (rpm) at the time of the event.The patient tolerated the exchange without issues and did not experience any adverse events.It was noted that the patient had been cannulated since (b)(6) 2024, and the motor and console had been in use since (b)(6) 2025.Review of the submitted video confirmed a high frequency rattle/grinding sound of low intensity that appeared to come from the operating pump and motor.The pump appeared to be properly positioned in the motor.Log files were retrieved from the returned console, and data from the reported event date of (b)(6) 2025 was reviewed.The system appeared to be operating as intended, and there were no notable alarms or findings in the reviewed log file data.The pedimag pump was not returned for evaluation.Review of the device history record (dhr) for the pedimag blood pump, lot #10148484 ((b)(6)), revealed no deviations from manufacturing or quality assurance specifications.The pedimag blood pump instructions for use (ifu) is currently available.The ifu contains the following warnings and cautions: ifu warning #12: frequent patient and device monitoring is recommended.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #15: always have a spare blood pump, back-up console, motor, and accessories available for change out.The section titled ¿pre-bypass checklist¿ warns to check the blood pump for irregular motion and noise during priming.The section titled ¿emergency back-up equipment¿ states that a sterile back-up blood pump circuit and priming accessories must be available.The current revisions of the instructions for use (ifu) and operation manual can also be found on the electronic ifu (eifu) page of the abbott website.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: PEDIMAG BLOOD PUMP
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 21256731
• Report Number: 3003306248-2025-00030
• Device Sequence Number: 15747837
• Product Code: DWA
• UDI-Device Identifier: 07640135140634
• UDI-Public: (01)07640135140634(10)10148484(17)250531
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 201-90052
• Device Catalogue Number: 201-90052
• Device Lot Number: 10148484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 12 KG