MAUDE Adverse Event Report: ESSENTIAL PHARMACEUTICALS/ BRETSCH / DR. FRANZ KOHLER CHEMIE GMBH CUSTODIOL; SET, PERFUSION, KIDNEY, DISPOSABLE

Lot Number	2021873
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient experienced an unexpected outcomes status post kidney transplant.When reviewing 3 cases all occurring during the same week one of the commonalities was the preservative solution.We are unsure if there is any correlation.Based on physician assessment the patient experienced tma status post transplant of unknown origin.

• Brand Name: CUSTODIOL
• Common Device Name: SET, PERFUSION, KIDNEY, DISPOSABLE
• Manufacturer (Section D): ESSENTIAL PHARMACEUTICALS/ BRETSCH / DR. FRANZ KOHLER CHEMIE GMBH
• MDR Report Key: 12066309
• Report Number: MW5102126
• Device Sequence Number: 19939559
• Product Code: KDL
• UDI-Device Identifier: 04033133010000
• UDI-Public: 04033133010000
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/23/2021

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
• Operator of Device: No Information
• Device Expiration Date: 08/04/2021
• Device Lot Number: 2021873
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 44 YR
• Patient Weight: 127