BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMICUS SEPARATOR SYSTEM

    MDR report key: 1517031 · Received October 16, 2009

    Report

    Report Number
    3004548776-2009-00001
    Event Type
    Malfunction
    Date Received
    October 16, 2009
    Date of Event
    June 2, 2009
    Report Date
    August 25, 2009
    Manufacturer
    FENWAL, INC.
    Product Code
    GKT
    PMA / PMN Number
    BK960005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE INVESTIGATION PERFORMED ON THE RETURNED MINI-PUMP ((B)(4), MFR DATE: 09/98) REMOVED FROM THE INSTRUMENT IT APPEARS THAT EXCESS GREASE WITHIN THE PUMP HOUSING HAD SOLIDIFIED CAUSING THE PUMP TO BIND SLIGHTLY. THE ADDITIONAL FRICTION LIKELY CAUSED THE RETAINING SCREW TO BACK OFF THE RETAINING WASHER. AT SOME POINT, THE MECHANICAL CONNECTION BETWEEN THE INTERMEDIATE GEAR AND THE PINION GEAR COULD NO LONGER MAINTAIN TRANSFER OF THE MOTOR TORQUE TO THE ROLLER GAGE; ULTIMATELY, RESULTING IN THE EVENT REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USER FACILITY INDICATED THAT A MALE DONOR WHO DONATED FREQUENTLY WAS UNDERGOING A DOUBLE NEEDLE AMICUS APHERESIS PROCEDURE. THE ADC RATIO WAS 11:1, CITRATE INFUSION RATE WAS 1.25 AND THE EXPECTED PLATELET YIELD WAS 9.54. WHEN 2497ML OF BLOOD HAD BEEN PROCESSED, THE OPERATOR REPORTED THE INSTRUMENT EXPERIENCED A CENTRIFUGE LINE BLOCKAGE ALARM. THE OPERATOR COULD NOT GET PAST THE ALARM CONDITION AND THE PROCEDURE WAS DISCONTINUED. A RED FIBRIN CLOT, DESCRIBED AS LONG AND STRING-LIKE WAS NOTED IN THE PLATELET COLLECTION PACK WHEN REMOVED FROM THE CENTRIFUGE. AT THAT TIME, THE OPERATOR NOTED THAT THE PLASMA IN THE PLATELET POOR PLASMA BAG WAS "JELLY-LIKE" BUT WAS NORMAL IN COLOR. IT WAS REPORTED THAT THE ANTICOAGULATION CITRATE DEXTROSE SOLUTION BAG DID NOT APPEAR TO HAVE DECREASED IN VOLUME SINCE PRIME, INDICATING THAT NO ACD HAD BEEN USED DURING THE PROCEDURE. THE DONOR DID NOT EXPERIENCE ANY ADVERSE EFFECTS. THE DONOR WAS RELEASED FROM THE CENTER AND WAS CONTACTED THE NEXT DAY BY THE CENTER. THE DONOR REPORTED TO THE CENTER THAT HE WAS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMICUS SEPARATOR SYSTEM AUTOMATED BLOOD CELL SEPARATOR GKT FENWAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR (B)(4) AMICUS APHERESIS KIT| MANUFACTURED BY FENWAL, INC.| DOUBLE NEEDLE, LOT FA9D28028