BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCS2

    MDR report key: 2220056 · Received August 9, 2011

    Report

    Report Number
    1219343-2011-00120
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    May 27, 2011
    Report Date
    August 9, 2011
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    JJX
    PMA / PMN Number
    BK040025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A HAEMONETICS FIELD SERVICE ENGINEER ON (B)(4), 2011 AND EVALUATED. THE ENGINEER CONFIRMED THAT COMPONENTS WERE DAMAGED CONSISTENT WITH A POSSIBLE FIRE. EVIDENCE OF HEAT, MELTED PLASTIC AND POSSIBLE FIRE WERE FOUND AT THE BACKPLACE POWER CONNECTOR AND VALVE CABLE. THE INVESTIGATION IS ONGOING. FOLLOW-UP REPORT TO BE FILED WHEN INVESTIGATION COMPLETE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HEAMONETICS ON (B)(6), 2011 AND ALLEGED THAT THE CENTRIFUGE WAS SMOKING WITH NO ALARM CODES ON THE PLASMA COLLECTION SYSTEM DURING THE FIRST DRAW PHASE. THE PROCEDURE WAS STOPPED IMMEDIATELY. NO DONOR INJURY OR REACTION REPORTED. NO OPERATOR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI