MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION BULK NON STER XCOAT DELPH PUMP; CENTRIFUGAL PUMP

Model Number	3ZZ164275X
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
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 during cardiopulmonary bypass, the pump made a squealing sound.No consequences or impact to patient.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 april 3, 2020 upon further investigation of the reported event, the following information is new and/or changed: b5(updated describe event or problem) g4 (date received by manufacturer) g7 (indication that this is a follow-up report) h2 (follow-up due to additional information) 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
New information received.Per user facility there seems to be a slight vibration on some cases and to alleviate the noise they relieved the tension of the clamp that holds the head onto the adapter.
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: d1(corrected brand name); d4 (additional device information - added expiration date); d4(additional device information - corrected model number); g4 (date received by manufacturer); g7 (indication that this is a follow-up report); h2 (follow-up due to additional information); h4 (device manufacture date); h6 (identification of evaluation codes 11, 3331, 4114, 3221, 22).Method code #1: 11 - testing of device from same lot/batch retained by manufacturer.Method code #2: 3331 - analysis of production records.Method code #3: 4114 - device not returned.Results code: 3221 - no findings available.Conclusions code: 22 - known inherent risk of device.The actual sample was not returned for evaluation, therefore, a thorough investigation cannot be performed.A retention sample from both of the potentially affected product code/lot number combinations 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 retention samples were observed for any running sound anomalies.No sound anomalies or abnormalities with the functionality were observed during the test.The noise and rotation issue was not able to be replicated 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: BULK NON STER XCOAT DELPH PUMP
• Common Device Name: CENTRIFUGAL PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9924040
• Report Number: 1124841-2020-00082
• Device Sequence Number: 16958402
• Product Code: KFM
• UDI-Device Identifier: 00699753450325
• UDI-Public: (01)00699753450325
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/12/2020

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: 03/31/2021
• Device Model Number: 3ZZ164275X
• Device Catalogue Number: N/A
• Device Lot Number: WE23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 04/09/2020; 05/08/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/28/2020; 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1