BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 3000 30ML HIGH FLOW PUMP

    MDR report key: 472328 · Received July 15, 2003

    Report

    Report Number
    1226348-2003-00151
    Event Type
    Malfunction
    Date Received
    July 15, 2003
    Date of Event
    June 10, 2003
    Report Date
    June 19, 2003
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED SYSTEMIC CHEMO AND COMPLAINED OF BLOATED FEELING. BECAME FAINT AT WORK AND WAS TAKEN TO ER WITH IRREGULAR HEART RATE. CONTINUED TO HAVE BLOATING SENSATION. IN 2003, PARACENTESIS PERFORMED REVEALING FRANK BLOOD. EXPLORATORY SURGERY PERFORMED TO CONTROL BLEEDING INVOLVED EVACUATING BLOOD, RE-SUTURING THE CATH TO THE ARTERY. PATIENT WAS DISMISSED AND REFILL OF PUMP TOOK PLACE. HEPATIC ARTERY PERFUSION (HAPS) HAS BEEN RECOMMENDED TO EVALUATE PUMPING STATUS. AT THE TIME OF COMPLAINT REPORTING, THE PATIENT WAS AT THE END OF THERAPY WITH ONE MORE FUDR CYCLE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 3000 30ML HIGH FLOW PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other