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

Model Number	201-90052
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
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 complete.
Event or Problem Description
It was reported that a centrimag pump was more loose than other pumps.The ventricular assist device (vad) coordinator reached out to inquire if there had been any manufacturing changes since the nurses had thought the pedimag pumps looked to have had a wider movement where the locking screw and the plastic crescent indention space was.They would turn back and forth more; however, all the screws are tight and in the groove.No issues to the pump, hardware, and patient were reported.The exact event date was unknown and could not be provided.Related manufacturer reference number: (b)(4).
Additional Manufacturer Narrative
Section a: there was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.Section b3: the exact event date was unknown and could not be provided.Section d4: model number, catalog number and primary udi corrected.Section h6: medical device problem code corrected.Manufacturer¿s investigation conclusion: the report of pedimag blood pump, lot number l08134-lb7, feeling loose could not be confirmed as no product was returned for evaluation.A specific cause for the reported event was unable to be determined.It was communicated that no additional information will be provided.Pedimag blood pump, lot number l08134-lb7, was not returned for evaluation.Review of the device history records for the pedimag blood pump, revealed no deviations from manufacturing or quality assurance specifications.The pedimag blood pump instructions for use (ifu), rev c is currently available and 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 #8: ensure the blood pump is properly locked into the centrimag motor.Ifu caution #15: always have a spare blood pump, back-up console, motor, and accessories available for change out.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: PEDIMAG BLOOD PUMP
• Common Device Name: 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18652780
• Report Number: 3003306248-2024-00404
• Device Sequence Number: 7084208
• Product Code: KFM
• UDI-Device Identifier: 07640135140634
• UDI-Public: (01)07640135140634(10)L08134-LB7(17)251113(11)221219
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 11/13/2025
• Device Model Number: 201-90052
• Device Catalogue Number: 201-90052
• Device Lot Number: L08134-LB7
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• 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: Unknown