MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TERUMO CARDIOVASCULAR PROCEDURE KIT; CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK

Model Number	75026
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hemoconcentrator sample was returned with the original tubing and drain plug still attached.The unit was decontaminated with 10% bleach solution and visually inspected was done from the provided photographs.No damage or defects were observed on the exterior of the hemoconcentrator.The certificate of conformance (coc) was reviewed for this component and the component was deemed conforming by the supplier.Lot number of the convenience kit was not provided, thus device history record (dhr) review could not be performed.The hemoconcentrator was then shipped overseas to our supplier for further investigation.When testing was initiated a fiber leak was discovered and further testing could not be done regarding the reported failure mode of the blood flow ceasing.It is suspected that the fiber leak started after initial use perhaps during transport back to terumo from the customer.There is no cause and effect relationship between a fiber leak and the reported issue of the blood flow ceasing.The root cause of ceased flow could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.(b)(4).
Event or Problem Description
It was reported that during a cardiopulmonary bypass (cpb) procedure, the hemoconcentrator blood flow suddenly ceased.The hemoconcentrator was changed out resulting in approximately 100 cc of blood loss.The surgery was completed successfully.There was no delay nor adverse consequences to the patient.
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 september 14, 2018.Upon further investigation of this reported event, the following information is new and/or changed: (b)(4).The sample was initially tested and saline solution was circulated through the blood phase.It was noted that there were pressure values much higher than typically seen which indicated blockage in the sample.The supplier surmised that the actual sample had been clogged with clots generated inside the fibers.It was discovered that there was leakage coming from broken fibers on the hc05.The leakage was large enough in volume that it prevented further performance testing from occurring.The supplier additionally performed a leak test review, complaint review and dhr review of the component part/lot number combination and could not find any issue or discrepancies with the component part/lot number combination.The hemoconcentrator instruction for use (ifu) indicates that "less than 100ml/min blood flow may cause blood coagulation in the device, and "adequate heparinization of the blood is required in order to prevent it from clotting in the system." 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 - CONVENIENCE TUBING PACK
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 28 howe street; ashland MA 01721
• MDR Report Key: 7878084
• Report Number: 1212122-2018-00016
• Device Sequence Number: 228234
• Product Code: OEZ
• UDI-Device Identifier: 00699753493629
• UDI-Public: (01)00699753493629
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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: 09/30/2019
• Device Model Number: 75026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1