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	Insufficient Information (4580)
Date of Event	05/24/2021
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 the pumphead was noisy.It is still unknown whether there was a delay in the procedure, whether the surgery was completed successfully or whether there was any effect on the patient, blood loos or results of the surgery.When the centrifuge was started, the blades inside the centrifuge brushed against the external bell, with a lot of noise, breaking many red blood cells and they changed it.The product was changed out.
Event or Problem Description
New information received: the event occurred during priming recirculation.Customer indicates that it did not affect any patient because the failure was during preparation of the extracorporeal circulation pump, at the beginning of priming recirculation, when a noise began as of the friction of the blades that is has inside.They had time to open a second custom without stopping the procedure and then replaced the centrifugal pump.There was no delay in the procedure and there was no blood loss as a result of the procedure.
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 june 11, 2021.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 11, 3331.4114, 3221, 4315).Type of investigation: #1: 11 - testing of device from same lot/batch retained by manufacturer.Type of investigation #2: 3331 - analysis of production records.Type of investigation #3: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected sample was not returned so a thorough investigation could not be conducted.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 pump was ran for one hour at various rpms from 900 up to 2400rpm.During this time, the pump was observed for sound anomalies.No sound anomalies or abnormalities with the functionality were observed during the test.Due to the lack of supporting information and the affected sample not being returned, it is not possible to determine a root cause to this event.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: 11982876
• Report Number: 1124841-2021-00138
• Device Sequence Number: 2995132
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2021

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 06/14/2021; 07/19/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 06/29/2021; 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1