MAUDE Adverse Event Report: ESSENTIAL PHARMACEUTICALS/ BRETSCH / ESSENTIAL PHARMACEUTICALS, LLC CUSTODIOL HTK SOLUTION; SET, PERFUSION, KIDNEY, DISPOSABLE

Lot Number 2021872

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 06/08/2021

Event Type  Injury  

Event Description

The risk management department was made aware on 06/17/2021 of a series of patients that have experienced unexpected outcomes status post transplant surgery that occurred the week of (b)(6) 2021.The patient experienced an unexpected adverse event after a kidney transplant from a live donor.When the team compared similarities the commonality is the use of a preservative.The patient had tma status post kidney transplant from unknown origin.The organization continues to further investigate and is reporting to create awareness if needed.

• Brand Name: CUSTODIOL HTK SOLUTION
• Type of Device: SET, PERFUSION, KIDNEY, DISPOSABLE
• Manufacturer (Section D): ESSENTIAL PHARMACEUTICALS/ BRETSCH / ESSENTIAL PHARMACEUTICALS, LLC
• MDR Report Key: 12075025
• MDR Text Key: 258889634
• Report Number: MW5102155
• Device Sequence Number: 1
• Product Code: KDL
• UDI-Device Identifier: 04033133010000
• UDI-Public: 04033133010000
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/24/2021

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: No Information
• Device Expiration Date: 08/04/2021
• Device Lot Number: 2021872
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 83