BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGEL CPRP PROCESSING SET USM

    MDR report key: 18993615 · Received March 28, 2024

    Report

    Report Number
    1220246-2024-01709
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 11, 2024
    Report Date
    June 24, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    ORG
    UDI-DI
    00888867084001
    PMA / PMN Number
    BK110046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE CAN BE ATTRIBUTED TO USER ERROR DUE TO IMPROPER INSERTION OF THE CASSETTE.

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN ABS-10063 PRP PROCESSING SET DID NOT EXPEL ANY RBCS, PPP, OR PRP. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220953 ANGEL CPRP PROCESSING SET USM PLATELET AND PLASMA SEPARATOR ORG ARTHREX, INC. ANGEL CPRP PROCESSING SET USM 2022010404 00888867084001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown