BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGEL CENTRIFUGE US (REFURBISHED)

    MDR report key: 17615696 · Received August 24, 2023

    Report

    Report Number
    1220246-2023-07624
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    July 19, 2023
    Report Date
    August 14, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    ORG
    UDI-DI
    00888867249585
    PMA / PMN Number
    BK110046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT IS CONFIRMED. FUNCTIONAL TESTING SIXTY ML OF HUMAN WHOLE BLOOD (13% ACD-A) WERE PROCESSED ON THE DEVICE WITH STANDARD SETTINGS AT SEVEN PERCENT HEMATOCRIT. THE DEVICE REPORTED OUTPUTS OF 17 ML PLATELET-POOR PLASMA (PPP), 40 ML RBC, AND 1 ML PRP. THE PRP VOLUME WITHIN THE SYRINGE WAS RECORDED AS 6.5 ML. NO ERROR MESSAGES WERE REPORTED DURING PROCESSING. ALIQUOTS OF THE WB AND PRP WERE ANALYZED FOR CBCS WITH THE SYSMEX XE-5000 HEMATOLOGY ANALYZER (TABLE 1). WHILE THE REPORTED EVENT WAS NOT REPLICATED, THE CONSOLE DID NOT FUNCTION AS EXPECTED. THE PRP WAS YELLOW IN COLOR, WHILE A 7% HCT PRP IS TYPICALLY AN ORANGE-RED. FURTHERMORE, THE PRP WAS PLATELET-REDUCED COMPARED TO BASELINE WHOLE BLOOD. BASED ON THE ABNORMALLY SMALL PPP AND LARGE RBC OUTPUT VOLUMES, IT APPEARS THE CONSOLE SWITCHED TO PRP OUTPUT TOO EARLY AND ESSENTIALLY PUT PPP IN THE PRP SYRINGE. REFER TO THE MEMO DEVICE EVALUATION ATTACHED. VISUAL EVALUATION FOUND SCRATCHES ON THE SCREEN DISPLAY AND NICKS AROUND THE EDGES OF THE CHAMBER PLATE. THE MOST LIKELY CAUSE OF THIS FAILURE IS ATTRIBUTED TO WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. MANUFACTURING DATE 07-2013.

    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) 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
    1122306 ANGEL CENTRIFUGE US (REFURBISHED) CENTRIFUGE ORG ARTHREX, INC. ANGEL CENTRIFUGE US (REFURBISHED) 14974791 00888867249585

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown