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	Cardiac Arrest (1762)
Date of Event	04/28/2023
Type of Reportable Event	Death
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the arterial flow decreased when restarting the extracorporeal circulation pump.As per the subsidiary, the procedure was for a heart surgery.The event occurred at the end of a procedure, which began at 9:00 p.M., in a patient who had an aortic dissection.The patient was very delicate, they reported that he had presented 8 previous cardiac arrests.The incident occurred at 02:00 hrs.When restarting the extracorporeal circulation pump, there is a decrease in arterial flow, which is why the revolutions of the centrifugal motor increase without being able to obtain more flow, for which they decided to switch it to a manual motor.The perfusionist changed the (disposable) head of the system 1 motor and placed it on the emergency crank; however, she did not give the necessary flow either (she was unable to raise the flow to more than 2 lt/min).Procedure was not completed.The patient expired.Product was changed out with an unknown minutes of delay.There was no blood loss.Concomitant medical products.Oxygenator brizio by nipro.Control np816572,ns1321.Motor np164267,ns:6579.Flow sensor np6382,ns2253.
Additional Manufacturer Narrative
Terumo has received the device for evaluation; however, 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.Component code: 925 - pump.Health effect - impact code: 1802 - death.Health effect - clinical code: 1762 - cardiac arrest.Medical device problem code: 2964 - 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 may 24, 2023.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date).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 manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 213, 67).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #3: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.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.The samples 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, and performed as expected.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
Arterial flow decreased when restarting the extracorporeal circulation pump.

• Brand Name: CENTRIFUGAL PUMP HEADS
• Common Device Name: CENTRIFUGAL PUMP HEADS
• 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: 16996302
• Report Number: 1124841-2023-00125
• Device Sequence Number: 7067177
• 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): 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 164275
• Device Catalogue Number: N/A
• Device Lot Number: 2G13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• 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: 05/03/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown