BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGEL CENTRIFUGE US (REFURBISHED)

    MDR report key: 23645476 · Received November 25, 2025

    Report

    Report Number
    1220246-2025-05183
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    November 3, 2025
    Report Date
    March 12, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    ORG
    UDI-DI
    00888867249585
    PMA / PMN Number
    BK110046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED ¿ WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PHOTOGRAPHS, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL FIELD INPUT ¿ ARTHREX HAS DETERMINED THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE IS ATTRIBUTED TO USER-RELATED FACTORS, SUCH AS AN INCORRECTLY LOADED DISPOSABLE SET OR IF THE PUMP ROTOR IS NOT PROPERLY INSTALLED. PER DFU-0262-3: IF THE PLATELET SENSOR IS UNABLE TO CALIBRATE, IT MAY BE DUE TO AN INCORRECTLY LOADED DISPOSABLE SET, A DIRTY SENSOR, OR THE SENSOR BEING TOO CLOSE TO AN EXTERNAL LIGHT SOURCE. ANY OF THESE CAN CAUSE INACCURATE DETECTION AND SEPARATION OF BLOOD COMPONENTS, LEADING TO INCONSISTENT PRP OUTPUT.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 11/05/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN ABS-10060R ANGEL CENTRIFUGE EXPERIENCED INCONSISTENT PRP OUTPUT. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2833657 ANGEL CENTRIFUGE US (REFURBISHED) CENTRIFUGE ORG ARTHREX, INC. ANGEL CENTRIFUGE US (REFURBISHED) 11843811 00888867249585

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown