BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMICUS APHERESIS KIT-FUNCTIONA LLY CLSD DBL NDL

    MDR report key: 338583 · Received June 19, 2001

    Report

    Report Number
    1420141-2001-00017
    Event Type
    Injury
    Date Received
    June 19, 2001
    Date of Event
    May 17, 2001
    Report Date
    May 17, 2001
    Manufacturer
    SAN GERMAN
    Product Code
    GKT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AN OPERATOR CROSSED SPIKED THE SALINE AND ACD SOLUTION WHICH ALLOWED THE KIT TO BE PRIMED WITH ACD. THIS ERROR WAS NOT IDENTIFED UNTIL AFTER THE DONATION BEGAN. THE CENTER BELIEVES THE DONOR RECEIVED APPROXIMATELY 100 ML OF ACD WITH THE FIRST RE-INFUSION. THE REPORT INDICATED THE DONOR INDICATED NOT FEELING WELL. NO DESCRIPTION OF SYMPTOMS OR EXPLANATION AS TO WHAT IS MEANT BY "NOT FEELING WELL" RECEIVED TO DATE. IT IS BELIEVED THAT THE DONOR LEFT IN GOOD CONDITION AS THERE WERE NO INDICATIONS OF A NEGATIVE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27850 AMICUS APHERESIS KIT-FUNCTIONA LLY CLSD DBL NDL AMICUS GKT SAN GERMAN NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other EXP: 11/02, COMPETITOR'S CODE UNK, LOT#00426C07A.| BAXTER SALINE PRODUCT CODE FKB1324G, LOT #00L07BT,