MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR COSTA RICA LLC TERUMO CARDIOVASCULAR PROCEDURE KIT; CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK

Model Number	73957-02
Medical Device Problem Codes	Leak/Splash (1354); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the cardioplegia set was leaking.When pressurized during set up, no leak was noticed, however, after flushing up to the field and running the vent, the negative pressure the vent created on the heat exchanger caused air to be drawn into the set.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was a blood loss of about 200 milliliters (ml).There was no delay, nor adverse consequences to the patient.
Additional Manufacturer Narrative
H3: 81 - evaluation is in progress, but not yet concluded.
Additional Manufacturer Narrative
Per the supplier evaluation, there was no anomaly, including a crack, observed upon visual inspection.Based on the investigation result, it was inferred that the luer thermistor was inserted deeper due to retightening, and stress continued to be applied to the port with the heat load during sterilization and until it was used.Deeply inserted thermistors can lead to cracks and leakage.The device history record (dhr) was review and no issues were noted related to this complaint.Gtin:(b)(4).Production identifier: (b)(4).If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Event or Problem Description
Per clinical review: this complaint involved a cp50 cardioplegia delivery unit that leaked during cardiopulmonary bypass.The leak occurred around the temperature thermistor located on the outflow port of the cp50 unit.The cp50 unit was changed out.There was a loss of approximately 200cc of blood.The cp50 unit was returned to the manufacturer for investigation.Upon inspection, the leak was confirmed on the complaint unit.The manufacturing records at that time revealed no anomalies in production.The most likely cause was workmanship error, possibly as a result of a loose thermistor being re-tightened by production associates and then being subjected to stress during heat sterilization.

• Brand Name: TERUMO CARDIOVASCULAR PROCEDURE KIT
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK
• Manufacturer (Section D): TERUMO CARDIOVASCULAR COSTA RICA LLC; calle 58; cartago, zona franca la lima 30106 ; CS 30106
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 18172664
• Report Number: 3017987980-2023-00003
• Device Sequence Number: 7610240
• Product Code: OEZ
• UDI-Device Identifier: 00699753507012
• UDI-Public: (01)00699753507012(10)0000411886(17)250430
• 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
• 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
• Report Date (Section B): 01/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 73957-02
• Device Lot Number: 0000411886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown