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 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

No sample was returned for this complaint but a sample photo was received.It appeared the break happened where the tip and the handle assembly is bonded together.No other signs of damage or deformation was noted from the photo.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.According to the intended use/indications for the sucker: "the surgical sucker/sump set is intended for use in a suction system to clear the operative field of blood or other fluid.It is not intended to ge sued as a probe or retractor.The precautions also within 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).

Event Description

The customer reported that during cardiopulmonary bypass (cpb) procedure, that one of the suckers broke.They stopped using the sucker, and surgery was completed successfully.There was no delay reported, no blood loss and no adverse event reported.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on october 28, 2021.Upon further investigation of the reported event, the following information is new and/or changed: h6 (investigation findings) -4248 - usage problem identified.H6 (investigation conclusions) -19 - cause traced to user.The supplier stated the break as a pressure break, highly likely due to misuse of the product.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• 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: 12715218
• MDR Text Key: 279894851
• Report Number: 1212122-2021-00007
• 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,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• 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: 11/03/2021
• 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