BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 17622772 · Received August 25, 2023

    Report

    Report Number
    1220246-2023-07629
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Date of Event
    July 19, 2023
    Report Date
    December 13, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    ORG
    PMA / PMN Number
    BK110046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION. 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 FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO A USER MODIFICATION.

    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 07/27/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN ABS-10060R ANGEL MACHINE DID NOT PRODUCE ANY PRP/PPP/RBC. THIS OCCURRED DURING A PRP INJECTION/ROTATOR CUFF REPAIR ON (B)(6) 2023, 180 CC'S OF WHOLE BLOOD WAS PROCESSED IN THE ANGEL MACHINE, BUT THE MACHINE DID NOT PRODUCE ANY PRP/PPP/RBC. THE SEPARATION CHAMBER WAS TOO PRESSURIZED TO REMOVE THE DISC FULL OF BLOOD. THEY TRIED TO MANUALLY PUMP OUT THE FLUID BY CUTTING THE TUBING AND DIRECTLY PULLING THE FLUID OUT WITH A SYRINGE TRYING TO GET THE DISC OUT. THE DISC WAS DAMAGED WHILE USING AN OSTEOTOME & MALLET TRYING TO PIERCE THE PLASTIC SURROUNDING THE FLUID SO THEY COULD GET THE BLOOD OUT WHICH RESULTED IN THE BLOOD LEAKING INTO THE MACHINE. THE CASE WAS COMPLETED WITHOUT THE PRP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086420 UNK PLATELET AND PLASMA SEPARATOR ORG ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown