BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE01- ORGAN RECOVERY OR PACK

    MDR report key: 23291039 · Received October 15, 2025

    Report

    Report Number
    1047429-2025-00004
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    June 18, 2025
    Report Date
    October 14, 2025
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    LRO
    UDI-DI
    10809160258095
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. AVID MEDICAL IS A CONVENIENCE KIT MANUFACTURER. THE COMPLAINT COMPONENT (PART NUMBER 520319) IS SUPPLIED BY (B)(4) A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO THE COMPONENT DISTRIBUTOR ON (B)(6) 2025. THE SUPPLIER HAS ADVISED THAT THE BAG IS MANUFACTURED BY BERRY GLOBAL INC. AND NOT SUITABLE FOR MEDICAL PURPOSES. THE ROOT CAUSE OF THE NONCONFORMANCE WAS THE INCLUSION OF A NON-MEDICAL COMPONENT IN A MEDICAL DEVICE CONVENIENCE KIT. THIS FAILURE RESULTED FROM INADEQUATE IDENTIFICATION AND DOCUMENTATION OF DESIGN INPUTS, WHICH LED TO THE INTRODUCTION OF A COMPONENT THAT DOES NOT MEET THE REQUIRED MEDICAL STANDARDS. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) HAS BEEN INITIATED TO CONDUCT A THOROUGH INVESTIGATION INTO THE ROOT CAUSE OF THIS ISSUE. THE CAPA WILL FOCUS ON ENHANCING DESIGN INPUT CONTROLS AND IMPLEMENTING ROBUST PROCESS MEASURES TO PREVENT THE RECURRENCE OF SIMILAR NONCONFORMITIES, ENSURING THAT ONLY COMPLIANT, MEDICAL-GRADE COMPONENTS ARE INCLUDED IN FUTURE MEDICAL DEVICE KITS. THE COMPLAINT BAG HAS BEEN REMOVED FROM THIS KIT AND QUOTING IS WORKING WITH CUSTOMER TO REPLACE WITH AN ALTERNATE BAG/CONTAINER WHICH IS APPROVED FOR MEDICAL STORAGE AND TRANSPORTATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(6). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    DURING AN ORGAN RECOVERY PROCEDURE, IT WAS DISCOVERED THAT THE PLASTIC BAG CONTAINED WITHIN THE AVID ORGAN RECOVERY PACK WAS NOT PROPERLY SEALED. SPECIFICALLY, THE BOTTOM OF THE BAG LACKED A PROPER SEAL. A RECOVERED LIVER FELL THROUGH THE BAG AND LANDED ON FLOOR. THERE WAS NO ADVERSE IMPACT TO THE DONOR OR ORGAN. THE ORGAN WAS USED BY THE INTENDED RECIPIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993286 LIFE01- ORGAN RECOVERY OR PACK LIFE01 - ORGAN RECOVERY OR PACK LRO AVID MEDICAL, INC. LLOF1000-17 1651709 10809160258095

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown