BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DC PLUM W/SEC CONVPN (48/CASE)

    MDR report key: 1934413 · Received November 23, 2010

    Report

    Report Number
    9615050-2010-00238
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 3, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K865060
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CHEMOTHERAPEUTIC AGENT. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED FROM THE Y-SITE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. INFO WAS REQUESTED FROM THE CUSTOMER CONTACT REGARDING THE NAME OF THE SOLUTION THAT LEAKED, IF THE SOLUTION WAS CLEANED UP ACCORDING TO THE USER FACILITY'S PROTOCOL, AND IF THE TUBING SET WAS REPLACED AND THE THERAPY RESUMED. NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DC PLUM W/SEC CONVPN (48/CASE) 80FRN FRN HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK