BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY (DISPOSABLE)

    MDR report key: 501528 · Received December 4, 2003

    Report

    Report Number
    1225520-2003-00012
    Event Type
    Malfunction
    Date Received
    December 4, 2003
    Date of Event
    November 19, 2003
    Report Date
    December 3, 2003
    Manufacturer
    HARVEST TECHNOLOGY
    Product Code
    JQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FILLED A DISPOSABLE WITH BLOOD, PLACED IT IN THE TRUNNION AND RAN A NORMAL CYCLE. UPON OPENING THE CENTRIIFUGE IT WAS OBSERVED THAT THERE WAS A SMALL AMOUNT OF BLOOD ON THE INSIDE OF THE CENTRIFUGE BOWL. THE DISPOSABLE WAS REMOVED AND THE PRP USED ON THE PT WITH NO COMPLICATIONS WHATSOEVER. THE DISPOSABLE AND INSTRUMENT WERE RETURNED AND EVALUATED BY HARVEST. IT WAS CONFIRMED THAT A SMALL AMOUNT OF BLOOD WAS IN THE CENTRIFUGE, THOUGH NOT A GREATER AMOUNT THAN WOULD BE SEEN DURING NORMAL USE. THE DISPOSABLE HAD A GREAT DEAL OF RED BLOOD CELLS REMAINING, THOUGH AN EXACT AMOUNT COULD NOT BE QUANTIFIED DUE TO LOSSES DURING SHIPPING AND HANDLING. IT WAS OBSERVED THAT THERE WAS A SMALL CRACK AT THE BASE OF THE DISPOSABLE AND THAT THE MOLDED GATE WAS HIGHER THAN SPECIFICATION WOULD PERMIT. IT IS LIKELY THAT THE GATE CONDITION CAUSED THE CRACK WHICH MAY HAVE ALLOWED A SMALL AMOUNT OF RED CELLS TO ESCAPE DURING THE CENTRIFUGATION PROCESS. ALTHOUGH THIS FAILURE MAY HAVE CAUSED SOME LEAKAGE, THE LEAKAGE IS A WASTE PRODUCT DURING THE PRP PROCEDURE AND THE LEAKAGE DOES NOT IMPOSE A SAFETY RISK IN THAT THE PRP IS USED AS AN ADJUNCT TO ANY SURGERY AND IS USED AT THE PHYSICIAN'S DISCRETION. THIS CONDITION HAD PREVIOUSLY BEEN IDENTIFIED AT HARVEST AND CORRECTIVE ACTION HAS BEEN IMPLEMENTED. THE BLOOD WHICH WAS SPILLED WAS CONTAINED WITHIN THE SEALED CHAMBER OF THE CENTRIFUGE AND WOULD NOT RESULT IN AN INJURY TO THE USER OR THE PT. THIS EVENT DID NOT RESULT IN AN EXPOSURE AS DEFINED BY OSHA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY (DISPOSABLE) PRP SYSTEM DISPOSABLE JQC HARVEST TECHNOLOGY FS-60 XJ2A74

    Patients

    Seq Age Sex Outcome Treatment
    1 *