BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGEL PRP SYSTEM CENTRIFUGE US (NEW)

    MDR report key: 19214549 · Received April 30, 2024

    Report

    Report Number
    1220246-2024-02631
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    April 5, 2024
    Report Date
    June 17, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    ORG
    UDI-DI
    00888867083974
    PMA / PMN Number
    BK110046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ONE UNPACKAGED ABS-10060 SERIAL NUMBER (B)(6) WAS RETURNED FOR INVESTIGATION. FUNCTIONAL TESTING RESULTS: 60ML OF BOVINE BLOOD WITH ACD-A WAS PROCESSED ON THE DEVICE WITH STANDARD SETTINGS AT SEVEN PERCENT HEMATOCRIT. THE DEVICE REPORTED OUTPUTS OF 39ML PLATELET-POOR PLASMA (PPP), 17ML RBC, AND 3ML PRP. THE PRP VOLUME WITHIN THE SYRINGE WAS RECORDED AS 3ML. NO OBVIOUS ERRORS IN FUNCTIONALITY OCCURRED DURING PROCESSING. ALIQUOTS OF THE WB AND PRP WERE ANALYZED FOR CBCS WITH THE HESKA HEMATOLOGY ANALYZER (TABLE 1). AFTER VISUAL INSPECTION OF THE PPP, NO VISUAL VARIATIONS IN THE PPP WERE NOTED. NOTE THE HCT PERCENTAGE IN THE PRP PRODUCED HAD EXPECTED CELLULAR CONCENTRATIONS. THE REPORTED FAILURE COULD NOT BE REPLICATED. VISUAL EVALUATION NOTED NO PROBLEMS WITH THE DEVICE. NO PROBLEM FOUND. REFER TO INVESTIGATION PHOTOS AND MEMO. COMPLAINT IS NOT CONFIRMED. CORRECTIONS: H.1 SET AS N/A. ARTHREX PREVIOUSLY SUBMITTED THIS EVENT AS A REPORTABLE MALFUNCTION OUT OF AN ABUNDANCE OF CAUTION. UPON RECEIVING ADDITIONAL INFORMATION FROM THE FIELD THAT CLARIFIED THE EVENT AND EVALUATION OF THE RETURNED DEVICES, IT HAS BEEN DETERMINED THAT THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER 21 CFR 803.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN ABS-10060 ANGEL MACHINES SENSOR SEEMS TO BE PRODUCING VERY DARK OUTPUT IN THE PPP. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143544 ANGEL PRP SYSTEM CENTRIFUGE US (NEW) CENTRIFUGE ORG ARTHREX, INC. ANGEL PRP SYSTEM CENTRIFUGE US (NEW) 12563802 00888867083974

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown