BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BODYGUARD 323 INFUSION PUMP

    MDR report key: 2538127 · Received April 11, 2012

    Report

    Report Number
    MW5025037
    Event Type
    Injury
    Date Received
    April 11, 2012
    Date of Event
    April 7, 2012
    Report Date
    April 11, 2012
    Manufacturer
    CME AMERICA, LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE NURSE ARRIVED AT THE PT'S HOME FOR A 5-FU TAKEDOWN AT THE END OF A 46-HOUR INFUSION. AFTER DISCONNECTING 5-FU FROM PT AND DE-ACCESSING THE INFUSION PORT, SHE DISCOVERED THAT THE 5-FU BAG WAS FULL. PER THE PT'S WIFE, DURING THE INFUSION, THE PUMP READ 3 ML/HR AND SHE COULD SEE "DRIPS" ON PUMP. ALL CLAMPS WERE OPEN AND THE PUMP ALARMED AT APPROPRIATE TIME FOR TAKEDOWN. UPON FURTHER NURSE INVESTIGATION, SHE NOTICED THAT THERE WAS EXCESS TUBING WITHIN THE PUMPING CHAMBER. THE TUBING WAS NOT FLAT AND SECURE AND WAS BUNCHED UP PREVENTING THE INFUSION OF THE DRUG. THERE WAS NO ALARM TO ALERT THE PT OF THIS PUMPING PROBLEM. THE PT DID NOT RECEIVE HIS 5-FU PRESCRIBED DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BODYGUARD 323 INFUSION PUMP BODYGUARD 323 FRN CME AMERICA, LLC 323

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability BODYGUARD MICROSET TUBING: CAT #A120-160XPS,| LOT #1079474