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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ESSENTIAL PHARMACEUTICALS/ BRETSCH / ESSENTIAL PHARMACEUTICALS, LLC CUSTODIOL HTK SOLUTION; SET, PERFUSION, KIDNEY, DISPOSABLE
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ESSENTIAL PHARMACEUTICALS/ BRETSCH / ESSENTIAL PHARMACEUTICALS, LLC CUSTODIOL HTK SOLUTION; SET, PERFUSION, KIDNEY, DISPOSABLE Back to Search Results
Lot Number 2021872
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/08/2021
Type of Reportable Event Serious Injury
Event or Problem 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.
 
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Brand Name
CUSTODIOL HTK SOLUTION
Common Device Name
SET, PERFUSION, KIDNEY, DISPOSABLE
Manufacturer (Section D)
ESSENTIAL PHARMACEUTICALS/ BRETSCH / ESSENTIAL PHARMACEUTICALS, LLC
MDR Report Key12075025
Report NumberMW5102155
Device Sequence Number3323520
Product Code KDL
UDI-Device Identifier04033133010000
UDI-Public04033133010000
Combination Product (Y/N)Y
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Risk Manager
Type of Report Initial
Report Date (Section B) 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
Operator of Device No Information
Device Expiration Date08/04/2021
Device Lot Number2021872
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/25/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
Patient Age55 YR
Patient Weight83
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