MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SINGLE STERILE XCOATED DELPHIN; CENTRIFUGAL PUMP

Model Number	164275X
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
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.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, the centrifugal pump was squeaky.No consequences or impact to patient.The product was changed out.Procedure was completed successfully.
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 february 14, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 213, 22).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 22 - known inherent risk of device.The returned sample was visually inspected in which no anomalies noted on the device.It was then set up on a drive motor and primed with a normal saline solution circuit.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 sample was observed for any running sound anomalies.No sound anomalies or abnormalities were noted during the test.A retention sample from the affected product code/lot number was obtained and tested the same way with no noted sound anomalies.The noise was not able to be replicated on the complaint 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: SINGLE STERILE XCOATED DELPHIN
• Common Device Name: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9713720
• Report Number: 1124841-2020-00032
• Device Sequence Number: 2927485
• Product Code: KFM
• UDI-Device Identifier: 00699753450325
• UDI-Public: (01)00699753450325
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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: 164275X
• Device Catalogue Number: N/A
• Device Lot Number: XN19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIVANOVA REVOLUTION.