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

Model Number 74921-02

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  malfunction  

Event Description

The customer reported that during cardiopulmonary bypass (cpb) procedure, that one of the suckers broke.The sucker was changed out, which resulted in a temporary delay in order to replace the sucker.No information was provided regarding blood loss.It was further stated that surgery was successfully completed.

Manufacturer Narrative

The sample was not returned.No sample or photos were received regarding this issue.From the complaint description is was stated that the suction wand tip broke off from the rest of the assembly.The device history record (dhr) was reviewed and no issues were noted related to this complaint.The certificate of conformance (coc) was reviewed for this component the supplier had performed 100% sucker/tip bend strength testing for the raw material lot.The supplier stated the break as a pressure break, highly likely due to misuse of the product.According to the instructions for use for the component "caution: care should be exercised when applying force to any sucker or sump set since excessive bending of the tube or tip could cause breakage." all available information has been placed on file in the quality management for appropriate tracking, trending, and follow-up.The case label gtin: (b)(4).The production identifier: (b)(4).

• Brand Name: TERUMO CARDIOVASCULAR PROCEDURE KIT
• Type of Device: CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 28 howe street; ashland MA 01721
• Manufacturer (Section G): SAME
• Manufacturer Contact: jean burns ; 28 howe street; ashland, MA 01721 ; 5082312417
• MDR Report Key: 12760653
• MDR Text Key: 285370541
• Report Number: 1212122-2021-00008
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 00699753499188
• UDI-Public: (01)00699753499188
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 74921-02
• Device Lot Number: Z24962901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1