BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARVEST SMARTPREP2 CENTRIFUGE SYSTEM,APC-120

    MDR report key: 2006226 · Received February 23, 2011

    Report

    Report Number
    1225520-2011-00001
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 7, 2011
    Manufacturer
    HARVEST TECHNOLOGIES CORPORATION
    Product Code
    JQC
    PMA / PMN Number
    K052925
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INDEPENDENT MEDICAL OPINION WAS OBTAINED ON THIS EVENT FROM (B)(4), HEMATOLOGIST. HE CONCLUDED THAT THE AUTOLOGOUS PRP PRODUCED BY UTILIZING THE HARVEST SMARTPREP2 CENTRIFUGE SYSTEM WOULD NOT BE THE CAUSE FOR THIS EVENT (OPINION ON FILE). THE PERFORMANCE OR QUALITY OF THE SMARTPREP2 CENTRIFUGE SYSTEM AND DISPOSABLE KIT WAS NOT IMPLICATED OR QUESTIONED IN THIS EVENT REPORT.

    Description of Event or Problem · 1

    FOLLOWING TOTAL HIP REPLACEMENT SURGERY ON (B)(6) 2011, AUTOLOGOUS PLATELET RICH PLASMA (PRP) PREPARED UTILIZING THE HARVEST SMARTPREP2 SYSTEM WAS ADMINISTERED INTRA-ARTICULARLY. ON/ABOUT (B)(6) 2011, POST OPERATIVELY THE PT HAD A FEVER AND AN ELEVATED WHITE BLOOD CELL COUNT. AS PART OF THE POST-OPERATIVE ROUTINE, THE PT WAS PLACED ON ANTIBIOTIC THERAPY. POST OPERATIVE CULTURES PROVIDED NEGATIVE OR NO GROWTH RESULTS. THE HIP IMPLANT WAS REMOVED ON (B)(6) 2011. REPORT ((B)(6)) ON (B)(6) 2011 REVEALED THE PT REMAINED HOSPITALIZED, IS RECOVERING, IS STABLE, AND IS AWAITING DOCTOR'S DECISION ON REPLACEMENT HIP IMPLANT. THERE WAS NO EVIDENCE TO SUGGEST THAT THE POST OPERATIVE COMPLICATION WAS RELATED TO THE ADMINISTRATION OF THE AUTOLOGOUS PRP OR THE PERFORMANCE OF THE HARVEST SMARTPREP2 SYSTEM. REPORT ((B)(6)) ON (B)(6) 2011, PT A LOT BETTER, REMAINS HOSPITALIZED, CULTURE RESULTS SHOW NO GROWTH. PRELIMINARY DOCTOR'S MEDICAL OPINION, THINKS IS AUTOIMMUNE RESPONSE. IMPLANT STATUS NOT REPORTED. REPORT ((B)(6)) ON (B)(6) 2011, REVEALED PT IS RESPONDING TO STEROID TREATMENT & IMPROVING. NO DECISION ON WHEN TO REIMPLANT. CULTURE RESULTS NO GROWTH. REPORTS ((B)(6)) EVENT PROBABLY IS NOT RELATED TO PRP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARVEST SMARTPREP2 CENTRIFUGE SYSTEM,APC-120 PLATELET CONCENTRATION SYSTEM JQC HARVEST TECHNOLOGIES CORPORATION APC-120-0060 864401-0045

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization (RECOTHROM, ZYMOGENETICS) HIP IMPLANT MFR| NOT REPORTED.| RECOMBINANT HUMAN THROMBIN