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

Model Number	77450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the tip of the sucker wand broke.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Event or Problem Description
Per clinical review: this complaint involved a perfusion tubing pack that had a sucker tip break off during cardiopulmonary bypass.There was no harm to the patient.The sucker was changed out with a new one.The sucker and sucker tip were not returned to the manufacturer for investigation.Pictures were shared of the broken sucker and clearly showed a jagged edge on the broken sucker tip which would indicate that the sucker was possibly being incorrectly used as this would be a pressure break rather than a solvent bonding issue.
Additional Manufacturer Narrative
Updated block: h6.The reported complaint was confirmed.Per supplier evaluation, the device history record was reviewed, and it showed that a 100% strength test was performed on each hex handle sucker to the stress limit of 4 pounds (lbs).All 500 pieces of the lot passed the strength test.A picture was provided by the user facility, and it was clear to see the break was at the bonding area of the hex handle sucker.On the picture with the tip only, it showed a portion that was broken with a jagged edge showing a pressure break rather than a bonding failure.It was most likely from the hex handle sucker being used as a probe or retractor that had more than a 4lb pressure placed on the medical device.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• 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: 18921794
• Report Number: 3017987980-2024-00010
• Device Sequence Number: 7477518
• Product Code: OEZ
• UDI-Device Identifier: 00699753513655
• UDI-Public: (01)00699753513655(10)0000468880(17)250430
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 06/18/2025

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: 04/30/2025
• Device Model Number: 77450
• Device Lot Number: 0000468880
• 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: 02/23/2024
• Supplement Date Received by Manufacturer: 05/09/2024; 05/28/2025
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 05/31/2024; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2023
• 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