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

Model Number	201-90052
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pedimag blood pump looked like it was correctly inserted into the centrimag motor, however, it was making a rattling noise while running.Specifically, the pump was running at 3500 rpm and there are no alarms.When tthe pump was pushed further into the motor the noise stopped.Customer was advised to make sure that the pump was fully inserted into the motor and the set screw was fully engaged.This was confirmed.Customer was asked to unscrew the set screw and reseat the pump into the motor and engage the set screw.This did not resolve the noise.It was then advised to remove the pump from the motor and choose another slot for the outlet of the pump to see if that resolved the noise.The customer opted not to do that as it would have required to interrupt support.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was later reported that no circuit intervention was taken, but tape was applied to maintain pressure to keep the head seated properly.No products were exchanged so no products would be returned.The noise was confirmed to have been coming from the blood pump.There was no adverse patient impact identified.
Additional Manufacturer Narrative
Section a: date of birth estimated as date of event as patient is newborn section d2b: corrected.Section h6: medical device problem code corrected.Manufacturer's investigation conclusion: the reported noise as well as the report of the pedimag blood pump not properly seated in the motor could not be confirmed.A specific cause for the reported events was unable to be determined.Multiple attempts were made to obtain additional information regarding the reported events; however, no further information was provided by the account.The pedimag pump was not returned for evaluation.The relevant sections of the device history records for l08334-lb7 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pedimag blood pump instructions for use (ifu) is currently available.This ifu also provides the following warnings and cautions: ifu warning #3: list hemolysis as a possible side effect.Ifu warning #9: it is intended that systemic anticoagulation be utilized while the device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.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 #8: ensure the blood pump is properly locked into the centrimag motor.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.The section titled ¿blood pump setup and operation¿ provides instructions for how to mount the blood pump on the motor.The following instructions are provided: to mount the blood pump on the centrimag motor, remove the blood pump from the inner tray and insert the blood pump into the motor receptacle.Place the bottom of the blood pump into the motor receptacle with the outlet port positioned in the large groove.Match the grooves on the periphery of the blood pump with the fittings on the motor receptacle.Rotate the blood pump counterclockwise until the blood pump locks securely into place.Thread the retaining screw clockwise to secure in place.The blood pump must be fully seated into the receptacle to function properly.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: 21954301
• Report Number: 3003306248-2025-00134
• Device Sequence Number: 18238267
• Product Code: KFM
• UDI-Device Identifier: 07640135140634
• UDI-Public: (01)07640135140634(10)L08334-LB7(17)260709
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 08/20/2025

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: 07/09/2026
• Device Model Number: 201-90052
• Device Catalogue Number: 201-90052
• Device Lot Number: L08334-LB7
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 05/05/2025; 08/18/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 05/29/2025; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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 Sex: Male
• Patient Weight: 3 KG