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

Model Number	75743
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: other (code unspecified, describe in h10).(81) - the sample was not returned.Per the user facility, during set-up of the device, it was observed that the volume was low and additional volume was added.About halfway through cpb, a noise was heard, and the venous line was observed to be hanging down and blood spilling onto the floor.The issue with the tubing happened on three previous occasions during set-up of the device.A tie band was placed on the venous line at the site of the dripping connector which stopped the leak.Two of the three cases were completed successfully with only one being cancelled.Per the customer's request, the connection where the disconnection occurred was specified not to be tie banded or bonded during the manufacturing process.Within the terumo cardiovascular kit ifu it it states: "push tubing past the innermost barb and secure with tie-band to prevent disconnection and leaks." the device history record (dhr) was reviewed and no issues were noted related to this complaint.All available information has been placed on file in the quality management for appropriate tracking, trending, and follow-up.Case label gtin: (b)(4).Production identifier: (b)(4).
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, there was a venous line disruption that caused an approximate 500-millimeter (ml) loss of blood.The surgical procedure was completed successfully.There was no delay and no adverse consequences to the patient.

• Brand Name: TERUMO CARDIOVASCULAR PROCEDURE KIT
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 16781824
• Report Number: 1212122-2023-00001
• Device Sequence Number: 6417211
• Product Code: OEZ
• UDI-Device Identifier: 00699753499850
• UDI-Public: (01)00699753499850
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2023

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: 01/31/2024
• Device Model Number: 75743
• Device Lot Number: 237101541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown