BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF CONV PP OL 2 C

    MDR report key: 1646490 · Received March 23, 2010

    Report

    Report Number
    9615050-2010-00051
    Event Type
    Malfunction
    Date Received
    March 23, 2010
    Date of Event
    February 4, 2010
    Report Date
    February 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. 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 NORMAL SALINE AT AN UNSPECIFIED RATE VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, A SECONDARY TUBING SET WAS CONNECTED TO THE PRIMARY TUBING SET FOR PIGGY BACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF OXALIPLATIN. THE PRIMARY SOLUTION CONTAINER WAS LOWERED BELOW THE SECONDARY SOLUTION CONTAINER. APPROXIMATELY 1 HOUR AFTER, THE CHEMOTHERAPY DELIVERY WAS INITIATED, THE CLINICIAN NOTED, THE CHEMOTHERAPY SOLUTION BACKFLOWED INTO THE PRIMARY SOLUTION CONTAINER. THE CLINICIAN CALCULATED THE VOLUME OF CHEMOTHERAPY SOLUTION THAT WAS DELIVERED TO THE PT. THE TUBING SETS WERE REPLACED AND THE DELIVERY OF THE REMAINING VOLUME OF CHEMOTHERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. 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 831755H

    Patients

    Seq Age Sex Outcome Treatment
    1 MFG ICU MEDICAL| SETSOURCE SECONDARY SET, LIST# Z2791, LOT# UNK