BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET WITH 0.2 MICRON FILTER AND CLAVE

    MDR report key: 1121803 · Received May 12, 2008

    Report

    Report Number
    9615050-2008-00133
    Event Type
    Malfunction
    Date Received
    May 12, 2008
    Date of Event
    March 5, 2008
    Report Date
    April 21, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    k865060
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    USER FACILITY VOLUNTARY MEDWATCH REC'D FROM CDRH THAT STATED: "PT RECEIVING A 3 HR CHEMOTHERAPY INFUSION. APPROX 2 HR 15 MIN INTO INFUSION NOTED FLUID DRIPPING ON THE FLOOR. NOTED APPROX 1 INCH DIAMETER PUDDLE ON THE FLOOR AND THE INFUSION PUMP WAS WET. NOTED LIQUID DRIPPING FROM THE TUBING. IT WAS DETERMINED AT THIS TIME TO STOP THE INFUSION DUE TO RISK OF EXPOSURE OF CHEMOTHERAPEUTIC AGENT TO PT AND STAFF. PT DID NOT GET ANY OF THE AGENT ON HER, HOWEVER, STAFF MEMBER DID. PROD WAS APPROPRIATELY DISCARDED. AGAIN DUE TO RISK INVOLVED WITH AGENT." UPON FURTHER QUERY, THE FOLLOWING INFO WAS PROVIDED THAT INDICATED A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. THE CUSTOMER CONTACT REPORTED THAT 2 HRS AND 15 MINS AFTER THE THERAPY HAD BEEN INITIATED, SOLUTION WAS NOTED TO BE DRIPPING ON THE FLOOR. IT WAS REPORTED AN UNSPECIFIED AMOUNT OF THE SOLUTION LEAKED ONTO THE HEALTHCARE PROFESSIONAL'S SKIN. THE HEALTHCARE PROFESSIONAL'S IRRITATED SKIN WAS WASHED WITH SOAP AND WATER. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL. THE TUBING SET WAS REPORTEDLY TAPED UP AND THE THERAPY WAS COMPLETED. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PT OR THE HEALTHCARE PROFESSIONAL. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUMSET WITH 0.2 MICRON FILTER AND CLAVE 80-FPA FPA HOSPIRA DE COSTA RICA LTD. NA 561935H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN