BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PUMP

    MDR report key: 1591229 · Received January 5, 2010

    Report

    Report Number
    1591229
    Event Type
    Malfunction
    Date Received
    January 5, 2010
    Date of Event
    December 3, 2009
    Report Date
    January 5, 2010
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER A MODIFIED RADICAL HYSTERECTOMY A DOUBLE CATHETER SUBFASCIAL INFUSION PUMP WAS PLACED IN THE CLOSED INCISION. WHEN THE NURSE ATTEMPTED TO REMOVE THE CATHETERS, THE RIGHT CATHETER CAME OUT WITHOUT DIFFICULTY. THE LEFT CATHETER BROKE WITH 2 CM IN LENGTH OUTSIDE HER SKIN. PATIENT WAS SENT TO INTERVENTIONAL RADIOLOGY FOR REMOVAL OF THE CATHETER. THE CATHETER WAS VISUALIZED WITH A CT SCAN OF THE LOWER ABDOMEN AND PELVIS. THE CATHETER DEMONSTRATED A KNOTTED PORTION WHICH WAS SEEN IN A SHOE STRING LIKE KNOTTED CONFIGURATION AT THE LINEA SEMILUNARIS JUST DEEP TO THE MEMBRANOUS FASCIA. THE CATHETER WAS SEEN TO TRAVEL MEDIALLY IN THE CEPHALAD DIRECTION THROUGH THE LEFT RECTUS ABDOMINIS MUSCULATURE AND EXIT THE MUSCLE BUT NOT THE SUBCUTANEOUS FAT CEPHALAD TO THE UMBILICUS. IT WAS APPROXIMATELY 3.7 CM DEEP TO THE SKIN. BASED ON THE LOCATION AND THE KNOTTED PORTION OF THE CATHETER, REMOVAL WOULD LIKELY REQUIRE SURGICAL INCISION AND EXPOSURE. THE CATHETER WAS NOT REMOVED IN INTERVENTIONAL RADIOLOGY THAT DAY. THE PATIENT WAS REFERRED BACK TO THE SURGEON FOR SURGICAL REMOVAL. THERE IS NO FURTHER INFORMATION AVAILABLE AS THERE IS NO RECORD OF THE REMOVAL AT THE FACILITY. WHEN THE PATIENT WAS IN INTERVENTIONAL RADIOLOGY, SHE REPORTED A SMALL AMOUNT OF PAIN IN THE REGION WHERE THE CATHETER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PUMP PUMP, INFUSION, ELASTOMERIC MEB I-FLOW CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR