MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TERUMO CARDIOVASCULAR PROCEDURE KIT

Model Number	77368
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation anticipated, but not yet begun.The device was not returned.The device return is still anticipated however.No issues were noted from the dhr review.All available information has been placed on file in the quality management for appropriate tracking, trending, and follow-up.(b)(4).Device not made available by end user.
Event or Problem Description
The customer reported that they had replaced the pack hemoconcentrator with a single sterile hemoconcentrator.During priming of the device for a cardiopulmonary bypass (cpb) procedure, a 'red tinge' was observed in the hemoconcentrator effluent.The product was not changed out and surgery was completed successfully.There was no delay reported, no blood loss and no patient consequences reported.
Additional Manufacturer Narrative
This follow-up is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular systems corporation in the initial report submitted january 26, 2021.Upon further investigation of this reported event, the following information is new and/or changed: g3 (date received by manufacturer).G6 (type of report) follow-up.H2 (if follow-up, what type) - additional information.H3 (device evaluated by manufacturer) - yes.H6 (type of investigation) - 3331 - analysis of production records.H6 (investigation findings) - 3233 - results pending completion of investigation.H6 (investigation conclusions) - 11 - conclusion not yet available.A sample was received.A visual/photographic evaluation was conducted and there were no cracks, crazing, or outwardly physical issues or damages noted.The sample was then shipped to our supplier for further evaluation.The supplier conducted a review of previous complaints for this component and did not find any previous complaints relating to this issue.The supplier also reviewed their production records for this component and there were no issues noted during the review.The physical sample has been received by our supplier as of 03/08/2021 and they will be conducting their evaluation.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
Additional Manufacturer Narrative
This follow-up is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular systems corporation in the initial report submitted january 26, 2021.The reported issue was not confirmed.The sample was sent to the supplier where they performed visual inspection and did not find any signs of deformity or damage.The actual sample was built into a test circuit and ultrafiltration performance was determined while bovine blood was circulated at 100ml/min and at 500ml/min.The obtained values were confirmed to be normal and met the factory's specification.No clogging was observed when the blood flowed in and no phenomenon in which the filtrate side turns red due to hemolysis during ultrafiltration.The sample was conforming to the factory's spec with no issues noted.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
Additional Manufacturer Narrative
This follow-up is submitted to the fda in accord with applicable regulations- and as indicated by terumo cardiovascular systems corporation in the initial report submitted 1/26/21.Upon further investigation of this reported event, the following information is new and/or changed.D8 (was this device serviced by a third party?) no g3 (date received by manufacturer) g6 (type of report) follow-up h2 (if follow-up, what type) correction h6 (component code) ¿ 558 - concentrator h6 (health effect ¿ impact code) ¿ 2199 ¿ no health consequences or impact all available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: TERUMO CARDIOVASCULAR PROCEDURE KIT
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 28 howe street; ashland MA 01721
• MDR Report Key: 11228908
• Report Number: 1212122-2021-00004
• Device Sequence Number: 3805869
• Product Code: OEZ
• UDI-Device Identifier: 00699753513235
• UDI-Public: (01)00699753513235
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/10/2021

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: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 77368
• Device Lot Number: Y42941749
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/01/2021
• Supplement Date Received by Manufacturer: 02/15/2021; 03/16/2021; 06/04/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 03/08/2021; 03/25/2021; 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1