BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SVENTED IV PUMPSET/C

    MDR report key: 1464505 · Received July 20, 2009

    Report

    Report Number
    9615050-2009-00157
    Event Type
    Malfunction
    Date Received
    July 20, 2009
    Date of Event
    June 10, 2009
    Report Date
    June 29, 2009
    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
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO HAZARDOUS CONTAMINATION, THE DEVICE WAS DISCARDED. A REPRESENTATIVE DEVICE FROM THE SAME LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER 11697. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPK. AND HAS A 510K OF K063239. 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 A LEAK OF A CHEMOTHERAPEUTIC AGENT. PRIOR TO PT USE, DURING THE PRIMING OF THE TUBING SET, AN UNSPECIFIED VOLUME OF A CHEMOTHERAPEUTIC AGENT LEAKED FROM AN UNSPECIFIED LOCATION ON THE TUBING SET. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE HEALTHCARE PROFESSIONAL. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SVENTED IV PUMPSET/C UNK FPA HOSPIRA COSTA RICA LTD. NA 480895G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK