MAUDE Adverse Event Report: EDWARDS LIFESCIENCES AORTIC PERFUSION CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number EZF24A

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned to edwards for evaluation.Evaluation is in progress.Any packaging non-conformance that results in a breach of the sterile package (i.E.Pinhole, tear or seal issue), has the potential to result in a serious infection.A definitive root cause could not be determined at this time.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

It was reported that the bottom of package of an aortic perfusion cannula was not sealed when the package was opened.The device was not used for the patient and replaced with another device.There were no patient complications reported.

Manufacturer Narrative

H3.Product evaluation: customer complaint that "the bottom of package of the ez-glide cannula was not sealed " was confirmed through image evaluation.In the pouch packaging photos provided, one end appeared unsealed and the other end appeared opened.Cannula pouch packaging was not returned with cannula.Device was returned with visible traces of blood and was examined in the biohazard area of lab.No other visible damage, contamination, or other abnormalities were observed from returned device.Photos attached by complaint handler appeared inconsistent with lab findings; pouch packaging was not returned.H10.Additional manufacturer narrative: updated sections d4 (expiration date), h3, h4, and h6.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.No manufacturing deficiency was identified.

Manufacturer Narrative

H10.Additional manufacturer narrative: supplier manufacturing defect was confirmed through image evaluation.Design, labeling, and ifu defects were not confirmed.Trend is in control.Fmea line item is appropriate.Capa action is required.Pra action is not required.The root cause of this event is supplier manufacturing.

Manufacturer Narrative

H11.Corrected data: updated section h6.Manufacturing, supplier, design, ifu, and labeling defects were not confirmed.Trend is in control.Fmea line item is appropriate.Capa action is required.Pra action is not required.Root cause cannot be determined at this time.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: AORTIC PERFUSION CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9295918
• MDR Text Key: 207360991
• Report Number: 3008500478-2019-00167
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/17/2019

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: 10/01/2021
• Device Model Number: EZF24A
• Device Catalogue Number: EZF24A
• Device Lot Number: 218185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 12/20/2019; 01/15/2020; 04/06/2020; 07/23/2020
• Supplement Dates FDA Received: 01/10/2020; 01/15/2020; 04/08/2020; 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1