MAUDE Adverse Event Report: EDWARDS LIFESCIENCES THIN-FLEX SINGLE STAGE 30F VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number TF030L

Device Problem Improper Flow or Infusion (2954)

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

Event Date 04/11/2023

Event Type  Injury  

Manufacturer Narrative

H10: additional narratives: there may be several failure modes that require an exchange of arterial or venous cannulae after the initiation of bypass.This will require a temporary interruption of cpb.Since the patient blood flow is dependent on cpb during this portion of the procedure the risk of injury is not remote.The device was not returned for evaluation, as device request is ongoing.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Event Description

Edwards received information that it was unable to remove venous blood during use of this tf030l single stage venous drainage cannula.After cannulation into inferior vena cava, this cannula was connected to the bypass.Shortly after that, the customer noticed that the blood could not remove intended flow volume.Although the customer attempted to adjust the position of the cannula, the problem was not resolved.So, the cannula was removed and exchanged with a non-edwards cannula prior to the initiation of bypass.There were no patient complications reported.The patient status was reported as recovering.The cannula was returned for evaluation.Per the customer, the causal relationship between the event and the cannula was unknown.The customer also commented that there was no visual abnormality observed in the cannula, and there was no problem with the connection found between the device and the tube of the bypass.The device was stored horizontally on the shelf in the storage room at the hospital.

Manufacturer Narrative

Corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: THIN-FLEX SINGLE STAGE 30F VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16877938
• MDR Text Key: 314657053
• Report Number: 2015691-2023-12788
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: TF030L
• Device Catalogue Number: TF030L
• Device Lot Number: 354410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 56 KG