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

Model Number	164275
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular that during prime, the centrifugal pump was noisy.The pump was removed, reinstalled with no change.No patient involvement.Product was changed out.Delay of approximately 5 minutes.Procedure was completed successfully.
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.
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 november 19,2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp 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 manufacture date).H6 (identification of evaluation codes 10, 11, 3331, 213, 22).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: 22 - known inherent risk of device.The affected samples were inspected upon receipt to show no visual anomalies.It was then built into a saline circuit and set up on a sarns drive motor.The rpm was set at 900 and ramped up by 300 rpm every ten minutes for one hour for a maximum of 2400 rpm.During each interval, the retention sample was observed for any running sound anomalies.No sound anomalies or abnormalities with the functionality were observed during the test.A retention sample from the affected sample product code/lot number combination was obtained and visually inspected with no anomalies noted.The retention was tested the same way and no sound anomalies or abnormalities with the functionality were observed during the test.The noise was not able to be replicated on the complaint or retention sample; however, the issue experienced by the customer is likely due to an abnormal interaction between the seal rotor and stator surfaces.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: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12845216
• Report Number: 1124841-2021-00258
• Device Sequence Number: 4546921
• Product Code: KFM
• UDI-Device Identifier: 00699753002333
• UDI-Public: (01)00699753002333
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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: 10/31/2022
• Device Model Number: 164275
• Device Catalogue Number: N/A
• Device Lot Number: XN15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• 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: 11/01/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2019
• 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