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

Model Number	73990-01
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	05/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample was returned to confirm this reported issue.The production run utilized two separate lg6ns lot numbers.It cannot be determined which lot number experienced the reported issue.The customer reported that they first observed the leak during prime and later reported that blood leaked through the hydrophobic membrane.This issue has been reported to our supplier.Our supplier implemented a corrective action (s-capa (b)(4)) which addressed issues similar to one reported here.However, the two lot numbers associated with this complaint were produced after implementation of the corrective action.Incoming inspection records were reviewed for both lots and no issues were noted.The device history record (dhr) was reviewed and there was an issue noted for the lg6ns.There was damage noted for three (3) filters related to the purge/vent port (1) and sampling port (2) damage.These filters were not incorporated into the production build.The cause cannot be determined for the reported issue.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, blood leaked across the hydrophobic membrane portion of the filter on two occasions.It resulted to a small amount of blood passing through the hydrophobic membrane of the filter.The purge port was closed and there was no blood loss external to the filter housing.The product was not changed out.There was no delay, and the surgical procedure was completed successfully.

• 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: 10140715
• Report Number: 1212122-2020-00003
• Device Sequence Number: 19361805
• Product Code: OEZ
• UDI-Device Identifier: 50699753484189
• UDI-Public: (01)50699753484189
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 06/10/2020

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: 08/31/2020
• Device Model Number: 73990-01
• Device Lot Number: WL24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1