BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF CONV PP OL 2 C

    MDR report key: 1860293 · Received September 23, 2010

    Report

    Report Number
    9615050-2010-00174
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 26, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K052722
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED BACKFLOW OF FLUID FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER 250ML OF AN UNSPECIFIED "FLUSH" SOLUTION. AT AN UNSPECIFIED TIME, AN UNSPECIFIED SECONDARY TUBING SET WAS CONNECTED TO THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF THREE UNSPECIFIED MEDICATIONS THAT WERE DELIVERED SEQUENTIALLY. THE PIGGYBACK DELIVERIES WERE REPORTED TO BE, "PREMEDICATIONS FOR CHEMO, TO PREVENT ALLERGIC REACTION. AFTER THE THIRD PIGGYBACK MEDICATION WAS DELIVERED, THE NURSE NOTED THAT THE DRIP CHAMBER OF THE PRIMARY TUBING SET WAS "COMPLETELY FULL" AND REPORTED THE 250ML PRIMARY SOLUTION CONTAINER "CLEARLY HAD MORE THAN 250ML OF SOLUTION IN IT." THE CUSTOMER CONTACT REPORTED, "THE PIGGYBACK MEDS HAD BACKED UP INTO THE PRIMARY BAG." THE CUSTOMER CONTACT INDICATED THAT THE SOLUTION IN THE PRIMARY SOLUTION CONTAINER WAS DELIVERED TO THE PT. IT WAS REPORTED THAT AFTER THE PREMEDICATIONS DELIVERY WAS COMPLETED, THE DELIVERY OF THE UNSPECIFIED CHEMOTHERAPEUTIC AGENT WAS INITIATED. THE CUSTOMER CONTACT REPORTED, THIS ADDED APPROX 35 MINS TO THE PT'S TREATMENT TIME. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LF CONV PP OL 2 C 80FPA FPA HOSPIRA COSTA RICA LTD. NA 851935H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED SECONDARY TUBING SET, MANUFACTURER UNK