BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NDHP 0.2 MICRN HP CL

    MDR report key: 2051363 · Received April 7, 2011

    Report

    Report Number
    9613251-2011-00062
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 14, 2011
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. 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 THE SILICONE SLEEVE OF THE CLAVE Y-SITE REMAINED IN THE OPENED POSITION; SUBSEQUENTLY, BLOOD LOSS WAS NOTED. THE OPTION-LOK MALE ADAPTER OF THE TUBING SET WAS CONNECTED TO THE PT'S UMBILICAL VEIN ACCESS. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF TPN, AT RATE OF 7ML/HR, VIA A PUMP. THE MALE ADAPTER OF AN UNSPECIFIED SYRINGE WAS CONNECTED TO THE CLAVE Y-SITE OF THE TUBING SET AND WAS BEING USED TO DELIVER GENTAMICIN 10MG/ML, AT A RATE OF 5.6MG/HR, VIA A SYRINGE PUMP. AFTER THE DELIVERY OF GENTAMICIN WAS COMPLETE, THE NURSE DISCONNECTED THE SYRINGE FROM THE CLAVE Y-SITE AND FLUSHED THE TUBING SET WITH 10ML OF HEPARIN SOLUTION USING AN UNSPECIFIED SYRINGE. AFTER AN UNSPECIFIED LENGTH OF TIME, THE NURSE FOUND THE PT "WITH POOLED BLOOD AND IV FLUIDS IN THE BED BY THE CLAVE." IT WAS REPORTED THE "CLAVE'S INNERPLUG DID NOT POP BACK INTO PLACE WHEN MED INFUSION WAS COMPLETED." THE VOLUME OF BLOOD LOSS WAS UNSPECIFIED. THE TUBING WAS CLAMPED. THE PHYSICIAN WAS NOTIFIED. IT WAS REPORTED THAT THE PT WAS ALREADY RECEIVING BLOOD VIA A SECOND PERIPHERAL ACCESS SITE. THE PHYSICIAN ORDERED AN ADDITIONAL 16ML OF BLOOD TO BE DELIVERED. THE CUSTOMER CONTACT REPORTED THAT A TOTAL OF 20ML OF BLOOD WAS DELIVERED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDHP 0.2 MICRN HP CL 80FPA FPA HOSPIRA, LTD NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA Required Intervention UNSPECIFIED SYRINGE, MANUFACTURED BY| BECTON DICKINSON AND COMPANY