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

Lot Number 2021873

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/10/2021

Event Type  Injury  

Event 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
• Type of Device: SET, PERFUSION, KIDNEY, DISPOSABLE
• Manufacturer (Section D): ESSENTIAL PHARMACEUTICALS/ BRETSCH / DR. FRANZ KOHLER CHEMIE GMBH
• MDR Report Key: 12066309
• MDR Text Key: 258618503
• Report Number: MW5102126
• 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: Patient
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Expiration Date: 08/04/2021
• Device Lot Number: 2021873
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 44 YR
• Patient Weight: 127