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 Patient Involvement (2645)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
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.(b)(4).Results pending completion of investigation.Conclusion not yet available.
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, a whistle sound was noticed from the pumphead.As per subsidiary, when the user facility change the flow the sound stops for a short period of time, and then restarts.No patient involvement.The product was changed out.The surgery 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 october 12, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h3 (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.) all available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.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 affected sample was inspected upon receipt with no anomalies noted.The affected sample was 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 returned 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 product code/lot number combination was obtained and visually inspected, no anomaly noted.The retention sample was 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 returned sample was observed for any running sound anomalies.No sound anomalies or abnormalities with the functionality were observed during the test.The noise was not able to be replicated on the affected sample or on the 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: 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: 10666523
• Report Number: 1124841-2020-00237
• Device Sequence Number: 4044168
• Product Code: KFM
• UDI-Device Identifier: 00699753450325
• UDI-Public: (01)00699753450325
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2020

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: No Information
• Device Expiration Date: 12/31/2022
• Device Model Number: 164275X
• Device Catalogue Number: N/A
• Device Lot Number: YA06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 10/14/2020; 11/17/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 11/04/2020; 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1