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

Model Number	71962-05
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample was not returned.The complaint sample, or photos of the issue were not received.Device history record (dhr) was reviewed and no issues were noted related to this complaint.The hemoconcentrators are 100% inspected for flow direction during the assembly of the convenience kits and no issues were noted during this process.The certificate of conformance (coc) was reviewed for this component and the component was deemed conforming by the supplier.The supplier has been notified of the issue and is investigating.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.(b)(4.(b)(6).
Event or Problem Description
It was reported that during a cardiopulmonary bypass (cpb) procedure, that the hemoconcentrator had a broken fiber.The hemoconcentrator was changed out.The surgical procedure was completed successfully.Minimal blood loss was reported.Additionally there was no delay.
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: date received by manufacturer.Indication that this is a follow-up report.Follow-up due to additional information.Identification of evaluation codes: (b)(4).The supplier determined that all inventory of the affected lot had been sold and shipped, back on january 26, 2018.The root cause of this issue has been determined to be related to a gelled formation of undissolved pvp used in the manufacturing process of the fiber.The mixing tank is cleaned on an as-needed basis and there likely was a buildup due to the frequency of cleaning of the mixing tank.The supplier has introduced a routinely scheduled preventive maintenance for the cleaning of the mixing tank.Additionally, there was re-validation performed on the fiber leak test apparatus used during production of blood fiber products.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 PORCEDURE KIT - CONVENIENCE TUBING PACK
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 28 howe street; ashland MA 01721
• MDR Report Key: 7878783
• Report Number: 1212122-2018-00017
• Device Sequence Number: 19345197
• Product Code: OEZ
• UDI-Device Identifier: 00699753503724
• UDI-Public: (01)00699753503724
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/18/2018

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: 71962-05
• Device Lot Number: WE23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1