MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS LIFESCIENCES AVID DUAL STAGE VENOUS DRAINAGE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number TF293702

Device Problems Material Discolored (1170); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

Out of box failures can result from many different product malfunctions, some less serious than others.If the malfunction occurring out of box would have been reportable had it occurred in the patient, then it should be reportable.This should be based on the actual failure mode or non-conformance.In this case, it was reported that the cannula showed visual defects and wasn't used.Received pictures, demonstrated few black spots of unknown origin on the cannula.The cannula is still usable; therefore, the potential of risk is not remote.The device was not returned for evaluation, as it is unavailable for return per follow-up with customer.The root cause of the event remains indeterminable.If new information becomes available, a supplemental report will be submitted.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.(b)(4).

Event Description

It was reported that a venous cannula had a visual defect prior to use.No patient was involved.

Manufacturer Narrative

H10: additional manufacturer narrative: updated h6 per new information received.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: EDWARDS LIFESCIENCES AVID DUAL STAGE VENOUS DRAINAGE CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10215143
• MDR Text Key: 202420190
• Report Number: 3008500478-2020-00200
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2022
• Device Model Number: TF293702
• Device Catalogue Number: TF293702
• Device Lot Number: 246647
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 08/08/2020; 07/23/2020
• Supplement Dates FDA Received: 08/10/2020; 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1