BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME RUBY 28/45 SP VT

    MDR report key: 1080561 · Received July 17, 2008

    Report

    Report Number
    1317749-2008-00124
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 24, 2008
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS "NOTICED PATIENT'S BLOOD LEAKING FROM VENOUS SIDE OF CATHETER. LIFTED CATHETER AND LARGER VOLUME LEAKED. SAW THERE WAS A LARGER HOLE ON ONE SIDE AND A SMALLER HOLE ON THE OTHER. WHEN THE CATHETER WAS NOT MANIPULATED, IT DID NOT LEAK AS MUCH. REPORTER STATED THE CATHETER WAS PLACED, AND THE PATIENT RAN FOR 1 1/2 HOURS ON THAT DAY WITH NO REPORTED ISSUES. REPORTER RAN THE PATIENT THREE DAYS LATER. AFTER TEN MINUTES, HE NOTICED THE BLOOD. THEY CONTINUED TO RUN THE PATIENT. PATIENT LOST APPROXIMATELY 15CC OF BLOOD OVER A 2 HOUR DIALYSIS TREATMENT. PATIENT WAS RUNNING AT 450, WHEN BLOOD WAS NOTICED REPORTER MOVED TO 400. PATIENT IS A MALE WHO IS MENTALLY HANDICAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME RUBY 28/45 SP VT DIALYSIS CATHETER MPB TYCO HEALTHCARE/KENDALL 8888128458 734415

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR