BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 2, 12 PACK

    MDR report key: 1755771 · Received July 14, 2010

    Report

    Report Number
    6000001-2010-01320
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4): THE PMA/510K NUMBER HAS BEEN UPDATED TO K041738.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CE INFUSOR LV 2 WHICH WAS LEAKING NEAR THE DISTAL END FLOW RESTRICTOR SITE. THE DEVICE WAS FILLED WITH 10.5 MILLIGRAMS/MILLILITERS 5-FLUOROURACIL (7719 MILLIGRAMS INTO 195 MILLILITERS OF NORMAL SALINE) WHEN THE LEAK WAS DISCOVERED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, AN UNKNOWN SUBSTANCE WAS NOTED ON THE DEVICE. THE TARGET LESION WAS SEVERELY CALCIFIED. THE PHYSICIAN ATTEMPTED TO LOAD THE ROTABLATOR ROTALINK PLUS 1.25MM BURR ON THREE ROTAWIRE FLOPPY GUIDE WIRES WITHOUT SUCCESS. THE PHYSICIAN WAS ABLE TO LOAD THE ROTABLATOR ROTALINK PLUS 1.25MM BURR ON THE FOURTH ROTAWIRE FLOPPY GUIDE WIRE AND ADVANCE THE BURR TO THE LESION, HOWEVER THE PHYSICIAN ENCOUNTERED DIFFICULTY WHILE ATTEMPTING TO ABLATE THE LESION. THEREFORE, THE PHYSICIAN EXCHANGED THE 1.25MM ROTALINK PLUS FOR ANOTHER 1.25MM ROTALINK PLUS AND ABLATED THE LESION SUCCESSFULLY, COMPLETING THE PROCEDURE SUCCESSFULLY FOLLOWING AN EXCHANGE TO A 1.5MM ROTALINK PLUS. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, THE PHYSICIAN NOTED "RUFOUS" MATERIAL ON THE TIP OF THE EXCHANGED 1.25MM ROTALINK PLUS BURR. THE PHYSICIAN WAS UNCLEAR IF IT WAS FOREIGN MATERIAL OR COAGULATED BLOOD ON THE TIP OF THE BURR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 2, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09N058

    Patients

    Seq Age Sex Outcome Treatment
    1