BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RED 4-CHANNEL HPT CARTRIDGE WITH PORCINE

    MDR report key: 24257087 · Received February 4, 2026

    Report

    Report Number
    1718389-2026-00007
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    June 28, 2023
    Report Date
    February 4, 2026
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    JOX
    PMA / PMN Number
    K894317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION AS PART OF A CAPA ACTION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF HR-ACT CARTRIDGES AND HMS RED CARTRIDGES, THE CUSTOMER REPORTED THAT THE PRODUCT WAS DELIVERED IN A DAMAGED, WET BOX. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WEREN'T ANY MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE OUTER BOX WAS DAMAGED, THE STERILE SEAL WAS DAMAGED AND PRODUCT WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317478 RED 4-CHANNEL HPT CARTRIDGE WITH PORCINE ANALYZER, HEPARIN, AUTOMATED JOX MEDTRONIC PERFUSION SYSTEMS 304-01POR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown