MAUDE Adverse Event Report: XVIVO PERFUSION AB PERFADEX PLUS; SYSTEM, PERFUSION, KIDNEY

Model Number 19850

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Description

There seems to be a discrepancy with the expiration date of the perfadex and lot# 201117641s.The outer container and sticker on product bag shows an expiration date of 20210831 and "8/21," respectively, but the stamped expiration date on the other side of the product shows "2/21." we are sequestering product and not using given this discrepancy.When we called the company to report, (b)(4), we could not get through.We did email them this information - info@xvivop-erfusion.Com (mailto:info@xvivoperfusion.Com).Technically i think this solution is a medical device, but felt that this may still be relevant to (b)(6).Mfr/labeler inaccurate info (label/labeling).Thank you.(b)(6).Submission id: (b)(4).

• Brand Name: PERFADEX PLUS
• Type of Device: SYSTEM, PERFUSION, KIDNEY
• Manufacturer (Section D): XVIVO PERFUSION AB
• MDR Report Key: 12894285
• MDR Text Key: 281591774
• Report Number: MW5105672
• Device Sequence Number: 1
• Product Code: KDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/06/2021

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?: No
• Device Model Number: 19850
• Device Catalogue Number: 19850
• Device Lot Number: 201117641S
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2021
• Patient Sequence Number: 1