BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE

    MDR report key: 2092986 · Received April 14, 2011

    Report

    Report Number
    9615050-2011-00259
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 17, 2011
    Report Date
    April 4, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND A 510K OF K052722. THIS REPORT REPRESENTS ALL THE INFORMATION 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 SIGMA PUMP. AT AN UNSPECIFIED TIME, THE MALE ADAPTER OF A SECONDARY TUBING SET WAS CONNECTED TO THE PROXIMAL CLAVE Y-SITE ON THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF DECADRON AND BENADRYL. THE PRIMARY SOLUTION CONTAINER WAS LOWERED BELOW THE SECONDARY SOLUTION CONTAINER. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED BACKFLOW OF SOLUTION FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. THE TUBING SETS WERE REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LF IV SET CONVRT PP W/BCCK VLV 2CLAVE UNK FPA HOSPIRA COSTA RICA LTD. NA 902125H

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR MANUFACTURED BY ICU MEDICAL INC.| SECONDARY TUBING SET, (B)(4)