BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT SET W/T

    MDR report key: 1431428 · Received July 29, 2009

    Report

    Report Number
    9613251-2009-00180
    Event Type
    Injury
    Date Received
    July 29, 2009
    Date of Event
    June 12, 2009
    Report Date
    July 1, 2009
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTACHMENT: USER FACILITY VOLUNTARY MEDWATCH REPORT WAS RECEIVED IN 2009. THE REPORT NUMBER WAS NOT PROVIDED. THE CUSTOMER INDICATED THE DEVICE IS NOT BEING RETURNED FOR EVAL. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. ADDITIONAL INFO FROM VOLUNTARY REPORT: 2009. HOSPIRA MICROBORE EXTENSION SET. T-CONNECTOR. HOSPIRA WORLDWIDE INC. MANUFACTURER. THE REPORTER DOES WANT THEIR IDENTITY DISCLOSED THE MFR.

    Description of Event or Problem · 1

    USER FACILITY VOLUNTARY MEDWATCH RECEIVED THAT STATED: "NURSE WENT TO CRIB TO ASSESS PT. NOTED T-CONNECTOR DISCONNECTED FROM PERIPHERAL IV CATHETER AND LAYING IN BED. ESTIMATED 45 GRAMS BLOOD LOSS. PT REQUIRED LAB WORK, ADMINISTRATION OF BLOOD PRODUCTS, AND TPN TO BE CONTINUED FOR ADDITIONAL DAYS. PT IS CURRENTLY BACK TO BASELINE." THE INFO PROVIDED INDICATED A DISCONNECTION. THE TUBING SET WAS CONNECTED TO AN UNSPECIFIED PERIPHERAL IV ACCESS AND WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF TPN. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE T-CONNECTOR DISCONNECTED FROM THE IV ACCESS SITE AND AN ESTIMATED 45 GRAMS OF BLOOD WAS LOST. THE PT WAS TREATED WITH UNSPECIFIED "BLOOD PRODUCTS." THERE WAS NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, THE CUSTOMER CONTACT DECLINED TO PROVIDE ADDITIONAL INFO. ADDITIONAL INFO FROM VOLUNTARY REPORT: NURSE WENT TO CRIB TO ASSESS PT. NOTED T-CONNECTOR DISCONNECTED FROM PERIPHERAL IV CATHETER AND LAYING IN BED. ESTIMATED 45 GRAMS BLOOD LOSS. PT REQUIRED LAB WORK, ADMINISTRATION OF BLOOD PRODUCTS, AND TPN TO BE CONTINUED FOR ADDITIONAL DAYS. PT IS CURRENTLY BACK TO BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXT SET W/T 80FPK FPK HOSPIRA LTD. NA 70134NS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 DA Life Threatening| R TPN