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

Model Number	3ZZ164275X
Medical Device Problem Codes	Leak/Splash (1354); Noise, Audible (3273)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2018
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, a leaked was observed on the adapters and the seal started to loosen up.No consequences or impact to the patient, product was changed not 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 (b)(6) 2018.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
Corrected information has been received from the user facility.During cardiopulmonary bypass, the delphin head squeaked throughout the entire case.Product was not changed out.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.(b)(4).The sample was not returned for evaluation.However, a retention sample from the same product code/lot number was obtained and visually inspected, in which no anomalies were noted.The sample was built into a saline circuit and then set up on a sarns drive motor.The rpm were set at 900 and ramped up by 300 rpm every ten minutes for one hour for a maximum of 2400 rpm.The noise 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.No abnormal / squeaky noises or performance issues were noted during the testing of the retention sample, either.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: 7545978
• Report Number: 1124841-2018-00107
• Device Sequence Number: 178717
• Product Code: KFM
• UDI-Device Identifier: 00699753450417
• UDI-Public: (01)00699753450417
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2018

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: 11/30/2019
• Device Model Number: 3ZZ164275X
• Device Catalogue Number: N/A
• Device Lot Number: WA13
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 06/18/2018; 07/05/2018
• Initial Report FDA Received Date: 05/25/2018
• Supplement Report FDA Received Date: 07/02/2018; 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1