BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME 23/40 KIT W/ SLOT

    MDR report key: 1005745 · Received March 1, 2008

    Report

    Report Number
    1317749-2008-00032
    Event Type
    Malfunction
    Date Received
    March 1, 2008
    Date of Event
    December 27, 2007
    Report Date
    February 4, 2008
    Manufacturer
    TYCO HEALTHCARE / KENDALL
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: FEBRUARY 28, 2008. AN INVESTIGATION IS CURRENTLY UNDER WAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON FEBRUARY 4, 2008, THAT A CUSTOMER HAD A PROBLEM WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTED, "THE CATHETER WORKED WELL WITH A FLOW OF 350 ML. PATIENT CAME IN FOR DIALYSIS TREATMENT IN 2007 AND WAS CONNECTED TO A FRESENIUS DIALYSIS MACHINE AND THE CATHETER WOULD ONLY SUCK IN AIR. PATIENT WAS THEN CHANGED TO GAMBRO MACHINE WHICH WORKED FINE. THIS SITUATION OCCURRED AGAIN AT WHICH TIME WE CONTROLLED THE CATHETER AND DISCOVERED THAT THE RED ADAPTOR WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME 23/40 KIT W/ SLOT DIALYSIS CATHETER MPB TYCO HEALTHCARE / KENDALL 8888145015 534702

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK