BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAXCEL PLUS APHERESIS CATHETER

    MDR report key: 1064244 · Received June 20, 2008

    Report

    Report Number
    MW5007381
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    April 20, 2008
    Report Date
    June 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD BOSTON SCIENTIFIC VAXCEL PLUS CENTRAL VENOUS CATHETER PLACED IN 2008 FOR APHERESIS OF PERIPHERAL BLOOD STEM CELLS AND SUBSEQUENT STEM CELL TRANSPLANT - SCT. PART OF PREPARATION FOR SCT WAS ADMINISTRATION OF HIGH-DOSE, UNDILUTED ETOPOSIDE APPROXIMATELY 13 DAYS LATER. AFTER INFUSION OF ETOPOSIDE, CLEAR PORTION OF CATHETER WAS FOUND TO HAVE TURNED OPAQUE. OTHER LUMEN OF CATHETER, WHICH DID NOT HAVE ETOPOSIDE INFUSED THROUGH IT, REMAINED CLEAR. BOTH LUMENS OF CATHETER SUBSEQUENTLY WERE UNABLE TO OBTAIN A BLOOD RETURN WHICH CLEARED FOLLOWING THE ADMINISTRATION OF TPA. THE CATHETER WAS SUBSEQUENTLY REMOVED UNDER MD ORDER AND PT REQUIRED PICC LINE PLACEMENT TO COMPLETE THE REMAINDER OF HER THERAPY. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: 1. LYMPHOMA. 2. STEM CELL TRANSPLANT. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO. PT RECEIVED UNDILUTED VEPESID THROUGH THIS CATHETER ON THAT DATE WHICH RESULTED IN THE LINE DISCOLORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL PLUS APHERESIS CATHETER UNK MSD BOSTON SCIENTIFIC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other