BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCS2

    MDR report key: 2193003 · Received July 21, 2011

    Report

    Report Number
    1219343-2011-00050
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 21, 2011
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    KSR
    PMA / PMN Number
    B040025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(4) 2011 AND ALLEGED POSSIBLE HEMOLYSIS IDENTIFIED IN THE COLLECTION BOTTLE DURING PLASMAPHERESIS ON THE PCS2 PLASMA COLLECTION SYSTEM. NO DONOR INJURY WAS REPORTED. NO OPERATOR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCS2 PLASMA COLLECTION SYSTEM KSR HAEMONETICS CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI