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

Model Number	77368
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Hemolysis (1886); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(code unspecified, describe) (device evaluation anticipated, but not yet begun.The device was not returned.However an unused hemoconcentrator from the same lot was returned.The sample was forwarded to the supplier for further evaluation.No issues were noted from the dhr review.The coc for the hemoconcentrator was reviewed and no issues were noted.All available information has been placed on file in the quality management for appropriate tracking, trending, and follow-up.(b)(4).
Event or Problem Description
The customer reported that during cardiopulmonary bypass (cpb) procedure, the pack exhibited varying levels of hemolysis, a 'pink tinge' to the hemoconcentrator effluent.The team primed their cpb circuit and recirculated as per their normal process and added the packed red blood cells (prbc) to the system after which, it was noted, there was red effluent from the hemoconcentrator.The circuit was utilized in the cardiopulmonary bypass surgery and once on bypass they customer commented that the red effluent eventually cleared up.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 12, 2021.The issue reported was not confirmed.The unused samples were sent to the supplier where they performed visual inspection and did not find any signs of deformity or damage.The samples were built into a test circuit and bovine blood was circulated at 100ml/min and at 500ml/min.The samples were conforming to the factory's spec with no issues noted.The supplier also reviewed their manufacturing records and product release records of the part and no issues were noted from the review.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 12, 2021.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 or 525 -tube; 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: 11159353
• Report Number: 1212122-2021-00003
• Device Sequence Number: 3718135
• 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
• 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: 12/24/2020
• Supplement Date Received by Manufacturer: 01/22/2021; 06/04/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/05/2021; 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1