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

Model Number 75295-01

Device Problems Crack (1135); Incomplete or Inadequate Connection (4037)

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

Event Date 09/30/2021

Event Type  malfunction  

Event Description

The customer reported that during cardiopulmonary bypass (cpb) procedure, there was a suspected possible molding/casting defect that resulted in a leak.A hairline fracture was observed in female luer component of 3/8" x 3/8" luered connector, located between pump and inlet to the oxygenator of cpb circuit.Bone wax was applied in order to stop the leak and get through the remainder of the case.It resulted in approximately 100ml of blood loss, and no delay was reported.The product was not changed out, surgery was completed successfully with no adverse consequences to the patient.

Manufacturer Narrative

The sample was not returned.The issue reported was not confirmed since no sample or sample photographs were received.Therefore, no definite root cause could be determined.The device history record (dhr) was reviewed and no issues were noted related to this complaint.Incoming inspection results for the component all passed.Trending on the convenience kit and the suspect component did not show any confirmed trends.All packs were signed for upon receipt with no indication of damage.All available information has been placed on file in the quality management for appropriate tracking, trending, and follow-up.Case gtin (b)(4).Production identifier (b)(6).

• 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: 12849943
• MDR Text Key: 285240688
• Report Number: 1212122-2021-00009
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 00699753501508
• UDI-Public: (01)00699753501508
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 75295-01
• Device Lot Number: Z20959596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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