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

Model Number	76810
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Hepatitis (1897)
Date of Event	12/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is directly related to medwatch 1212122-2019-00002, same event.(b)(4).The device history record (dhr) was reviewed and no issues were noted related to this complaint.The certificate of conformance (coc) was reviewed and the component was deemed conforming by the supplier.It was noted by the customer that the flow through the filter as the time of the incident was over 500 ml/min.The flow through the filter was noted as 30% greater than the recommended 350 ml/min as stated in the instructions for use.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 the leukocyte filter burst within minutes of the initiating its use.The perfusionist (user of the device) was exposed to infectious blood when it got into the users' right eye.The user was wearing gloves, no protective gown or eye protection was utilized.The user went to the emergency room and was started on antiviral medication.

• Brand Name: TERUMO CARDIOVASCULAR PROCEDURE KIT
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK
• Manufacturer (Section D): TERUMO CARDIOVACULAR SYSTEMS CORPORATION; 28 howe street; ashland MA 01721
• MDR Report Key: 8232533
• Report Number: 1212122-2019-00003
• Device Sequence Number: 950518
• Product Code: OEZ
• UDI-Device Identifier: 00699753509054
• UDI-Public: (01)00699753509054
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 76810
• Device Lot Number: WM01
• 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: 12/15/2018
• Initial Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention