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

Model Number	164275X
Medical Device Problem Codes	Leak/Splash (1354); Noise, Audible (3273)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/01/2020
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).
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the delphin cone leaked and made a loud noise.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 september 25, 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.
Event or Problem Description
Corrected date initial information received by the manufacturer to september 1, 2020.
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, 4210, 4307).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: 4210 - leakage/seal.Conclusions code: 4307 - cause traced to component failure.The affected sample was visually inspected and confirmed the presence of fluid in the back housing of the pump.No other visual anomalies were found.It was setup in a circuit with saline to check for active leakage and noise.No external leakage was observed.There was a noise from the pump, however, the noise did not resemble a pump squeal or mechanical noise.The noise appeared to come from the magnet rotor spinning in fluid.At the end of test, the back housing of the pump was visually inspected, showing that additional fluid was in the back housing.The sample was then attached to a circuit, and filled with water and connected to a vacuum source, vacuum was applied to the returned device, after few seconds air bubbles from the back housing was seen between the seal rotor and stator.That confirmed the thin crack between the seal rotor and stator.A retention sample from the same product code/lot number combination was obtained.The sample was attached to a circuit, and filled with water and connected to a vacuum source, vacuum was applied to the returned device.No leakage was observed.All centrifugal pumps are visually inspected in process and 100% leak tested at the final leak tester prior to packaging.It is likely that the seal failure could be caused by damage to seal rotors or issues with the compression.A damage sealing surface could allow channels to form and allowing fluid to penetrate to the back housing.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: 10588333
• Report Number: 1124841-2020-00226
• Device Sequence Number: 19489830
• Product Code: KFM
• UDI-Device Identifier: 00699753450325
• UDI-Public: (01)00699753450325
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 11/04/2020

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: 03/31/2023
• Device Model Number: 164275X
• Device Catalogue Number: N/A
• Device Lot Number: YE03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 10/06/2020; 10/28/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/28/2020; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1