BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCS+ 9000 SYSTEM

    MDR report key: 2822781 · Received November 2, 2012

    Report

    Report Number
    1219343-2012-00166
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 16, 2012
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    GKT
    PMA / PMN Number
    BK080038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS NOT BEEN EVALUATED. THE CUSTOMER SENT PICTURES OF THE FILTER, WHICH WAS CONFIRMED TO BE BURST OPEN WITH SPLATTERED BLOOD. THE ROOT CAUSE CANNOT BE DETERMINED WITHOUT BEING ABLE TO EVALUATE THE DEVICE AND THE DISPOSABLE KIT. HAEMONETICS (B)(4).

    Description of Event or Problem · 1

    HAEMONETICS RECEIVED A COMPLAINT ON (B)(6) 2012 FOR A REPORT OF "FILTER BURSTED AT THE LAST RETURN (NO KINK IN TUBING)." NO DONOR OR OPERATOR INJURY WAS REPORTED. THE SYSTEM HAS BUILT IN SAFETY FAULTS TO ALERT THE OPERATOR THAT THE PRESSURE AT THE DPM IS BEING EXCEEDED. THERE WOULD ALSO BE ALERTS AS TO CHECK FOR KINKS IN THE LINE. THERE ARE SEVERAL OPERATOR ERRORS THAT TO OCCUR FOR THE RESULT OF BURST FILTER TO OCCUR. THE RESULT OF THESE ISSUES NOT BEING CHECKED BY THE OPERATOR IS THE SPLATTER OF BLOOD PRODUCTS. IF THIS WERE TO RECUR, THE POTENTIAL FOR SERIOUS INJURY DUE TO THE SPLATTER ON PERSONS IN THE AREA IS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCS+ 9000 SYSTEM GKT HAEMONETICS CORP. 120621531

    Patients

    Seq Age Sex Outcome Treatment
    1