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

Model Number	73454-01
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation is anticipated but not yet begun.The sample photograph was received and sample is expected to be received.Device history record was reviewed and no issues were noted related to this complaint.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up (b)(4).
Event or Problem Description
During a cabg, the cardioplegia line was observed to have a piece of plastic floating within the line.This line was contained in a perfusion pack.
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 october 18, 2018.Upon further investigation of this reported event, the following information is new and/or changed: (b)(4).The sample was received and decontaminated.Upon visual inspection of the sample from line #4, it was noted there was a green colored thread found securely bonded between the connector barbs and the tubing and it did not extended into the fluid pathway, the thread extended 0.31¿ external to the connector.It was determined to have originated from green finger tape utilized by the assemblers.The process has been modified to prevent this issue.It now requires that if finger tape is utilized that it be covered.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.
Event or Problem Description
The customer also provided the following information, the product was not changed out, there was no delay to the procedure, no blood loss or patient injury.

• 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: 7978246
• Report Number: 1212122-2018-00019
• Device Sequence Number: 1368528
• Product Code: OEZ
• UDI-Device Identifier: 00699753501034
• UDI-Public: (01)00699753501034
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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: 73454-01
• Device Lot Number: WE02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1