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

Model Number	76847
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	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation anticipated, but not yet begun.The sample photograph was received confirming the reported issue.There was evidence of blood on the surface of the hemoconcentrator fibers, internal to the device.The device history record (dhr) was reviewed and no issues were noted.The certificate of conformance (coc) indicated the lot was deemed conforming by the supplier.The sample has not yet been received.It is anticipated that the actual sample will be returned for decontamination and further evaluation.All available information has been placed on file in the quality management for appropriate tracking, trending, and follow-up.The case label gtin: (b)(4).The production identifier: (b)(4).
Event or Problem Description
The customer reported that during a blood prime of the cardiovascular procedure kit, there was a 1-2 milliliter blood leak, internal to the hemoconcentrator.The device was changed out, there was no delay to the procedure and the surgery was successfully completed.There were 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 july 12, 2019.D10 (indicates device available for evaluation); g4 (date received by manufacturer); g7 (indication that this is a follow-up report); h2 (follow-up due to additional information and device evaluation); h3 (indicates device evaluated); h6 (identification of method code).H6 method: 10-actual device evaluated.A sample was received and was visually inspected prior to decontamination.There was no visible external damage on the body of the hemoconcentrator or the end caps.Also the original tubing and tie bands were located on both end caps of the hemoconcentrator.The sample has been sent to the supplier for further 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 august 1, 2019.G4 (date received by manufacturer).G7 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H6 (identification of method code).H6: results - 4242 maintenance of manufacturing machinery.H6: conclusions - 51 cause traced to maintenance.The sample was received by the supplier where they were able to confirm the reported issue.The supplier determined this issue to be an isolated issue where the defect rate was.09% of the total lot produced.The supplier 100% fiber leak tests all product during the production process.The root cause of this issue can be attributed a supplier issue where there was a fiber wall defect due to the fiber spin process.There was cyclic dimer crystal build up in the tubing, fitting and dope pumps during production.The supplier has replaced tubing faceplates and tubing.They have also cleaned dope pumps used during the process.The supplier has also implemented numerous preventative actions such as establishing preventative maintenance for tubing changes and increasing preventative maintenance frequency dope pump cleaning.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: 8786246
• Report Number: 1212122-2019-00007
• Device Sequence Number: 16734239
• Product Code: OEZ
• UDI-Device Identifier: 00699753509436
• UDI-Public: (01)00699753509436
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 09/13/2019

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: 04/30/2021
• Device Model Number: 76847
• Device Lot Number: X20894632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 07/12/2019; 09/11/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/01/2019; 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1