MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CARDIOVASCULAR PROCEDURE KIT; N/A

Model Number	75513-01
Medical Device Problem Codes	Partial Blockage (1065); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, foreign material film blocked the level detector signal resulting to the pump did not detect a low level even with 0 volume in the reservoir on a pediatric case.As per the perfusionist, after bypass, it was noticed that the bottom of the venous reservoir had "something" in it.The substance then moved from the bottom of the reservoir into the oxygenator.*no consequences or impact to patient.*product was changed out.*procedure was completed successfully.
Additional Manufacturer Narrative
The reported malfunction is specific to device 3zz*fx15re30ca lot 3k14 that was manufactured into the convenience kit referenced in d4.Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.
Additional Manufacturer Narrative
Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.H3: evaluation is in progress, but not yet concluded.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: g3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H3 (device evaluated by manufacturer).H6 (identification of evaluation codes 10, 3331, 3221, 4315).The oxygenator was inspected upon receipt, no substance was noted to be inside of the unit.The affected reservoir was not returned for evaluation; therefore, a thorough investigation could not be performed regarding the film blocking the level detector.Without the reservoir being returned, a thorough investigation could not be performed, and a definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CARDIOVASCULAR PROCEDURE KIT
• Common Device Name: N/A
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 19945109
• Report Number: 1124841-2024-00088
• Device Sequence Number: 8178283
• Product Code: OEZ
• UDI-Device Identifier: 00699753527683
• UDI-Public: (01)00699753527683(10)0000480427(17)250930
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/20/2025

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: 09/30/2025
• Device Model Number: 75513-01
• Device Catalogue Number: N/A
• Device Lot Number: 0000480427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 08/12/2024; 02/26/2025
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/05/2024; 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2023
• 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
• Patient Sex: Unknown