MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CENTRIFUGAL PUMP HEADS

Model Number	164275
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular that during other procedure, they noticed atrial septal defect and abnormal drainage.As per subsidiary, during the surgical procedure of a patient with interatrial communication (atrial septal defect - asd) plus abnormal drainage, the necessary flow cannot be achieved, despite having the head at 3600 rpm.Once the surgery was completed and the patient left the operating room, the following tests were performed: with the patient's circuit as is, 1550 rpm was infused with a flow of 0.250 l/min, with a circuit only of the centrifugal head and water the result was 240 rpm with a flow of 1.78 l/min, and finally, only with the head used during surgery (with blood) the result was 660 rpm with a flow of 5.00 l/min.Technical team indicates that the equipment is working correctly.In order to mitigate issue, re-cannulation was performed without changed in flow, however, after unclamping the aorta, the flow improved.Additionally, the patient condition is stable.No known health consequences or impact to patient.Product was not changed out.Procedure completed successfully with known delay.
Additional Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.H6: component code: pump health effect - impact code: 2199 - no health consequences or impact.Health effect - clinical code: 4582 - no clinical signs, symptoms or conditions.Medical device problem code: 2954 - infusion or flow problem.Investigation findings: 3233 - results pending completion of investigation.Investigation conclusions: 11 - conclusion not yet available.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on december 4, 2023.Upon further investigation of the reported event, the following information is new and/or changed: a1 (added patient's identifier) d4 (additional device information - added expiration date) d9 (device availability - added date returned to manufacturer) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information and device evaluation) h3 (device evaluated by manufacturer) h4 (device manufacturing date) h6 (identification of evaluation codes 10, 11, 3331, 213, 67) the affected sample was inspected upon receipt with no visual anomalies noted.The affected sample and a retention sample from the same lot were setup to check flow rates at the outlet of the pump.Both were tested flow rates that span the pumps rated flow capability across the pumps rpm range.The pump outlet pressure was then measured at the respective flow and speed.When compared to the pump flow chart found within the pump ifu, the units were both confirmed to functioned as intended.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CENTRIFUGAL PUMP HEADS
• Common Device Name: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 18258258
• Report Number: 1124841-2023-00270
• Device Sequence Number: 19809544
• Product Code: KFM
• UDI-Device Identifier: 00699753002333
• UDI-Public: (01)00699753002333
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K112229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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: 07/31/2025
• Device Model Number: 164275
• Device Catalogue Number: N/A
• Device Lot Number: 2K27A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OXY, HEMOCONCENTRATOR AND AF - BRIZIO
• Patient Sex: Unknown