BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRESENIUS KABI COM. TEC BLOOD CELL SEPARATOR

    MDR report key: 2823737 · Received October 24, 2012

    Report

    Report Number
    3004152132-2012-00001
    Event Type
    Other
    Date Received
    October 24, 2012
    Date of Event
    September 22, 2012
    Report Date
    October 23, 2012
    Manufacturer
    FRESENIUS HEMOCARE GMBH
    Product Code
    LKN
    PMA / PMN Number
    K060734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNITED STATES AGENT FOR THE PRODUCT LISTED IS FRESENIUS KABI, USA LLC. THE TPE DISPOSABLE SETS (PART #9400451, LOT #BAT051) USED WITH THE NAME DEVICE HAVE BEEN RETURNED TO THE FRESENIUS MFG SITE FOR INVESTIGATION. ALL RESULTS FROM THE INVESTIGATION WILL BE SENT AS A FOLLOW-UP TO THIS MDR REPORT.

    Description of Event or Problem · 1

    PT UNDERGOING THERAPEUTIC PLASMA EXCHANGE (TPE) TREATMENT. WITHIN 40 MINS. OF THE PROCEDURE, PT COMPLAINED OF "FEELING FUNNY" WITH SOME TINGLING AROUND THE MOUTH. THE PROCEDURE WAS STOPPED; 1500 ML OF ALBUMIN AT A FLOW RATE OF 68ML/MIN WAS INFUSED DURING THE 40 MIN BEFORE THE PROCEDURE WAS STOPPED. THE PT WAS MONITORED POST PROCEDURE BY STAFF AND EVALUATED BY A PHYSICIAN. AFTER EVALUATION BY A PHYSICIAN, PT WAS GIVEN LASIX AND DISCHARGED HOME THAT SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS KABI COM. TEC BLOOD CELL SEPARATOR SEPARATOR, AUTOMATED, BLOOD CELL, PLASMA LKN FRESENIUS HEMOCARE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other