BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDHP 0.2 MICRN HP CL

    MDR report key: 2160283 · Received April 28, 2011

    Report

    Report Number
    9613251-2011-00081
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 28, 2011
    Report Date
    April 6, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED LEAK; SUBSEQUENTLY BLEED BACK WAS NOTED. THE EXTENSION SET WAS CONNECTED TO AN UNSPECIFIED PLUMSET AND WAS USED TO DELIVER CISPLATIN 70MG/250ML, AT AN UNSPECIFIED RATE, VIA A PLUM PUMP. IT WAS REPORTED THAT AFTER THE DELIVERY OF CISPLATIN WAS COMPLETE, THE NURSE DISCONNECTED THE PLUMSET FROM THE CISPLATIN SOLUTION CONTAINER. THE PLUMSET WAS THEN CONNECTED TO A UNSPECIFIED 5% DEXTROSE IN 1/2 NORMAL SALINE SOLUTION CONTAINER. THE PUMP WAS REPROGRAMMED TO DELIVER THE DEXTROSE SOLUTION AT A RATE OF 250ML/HR AND THE DELIVERY WAS STARTED. IT WAS REPORTED THAT "WITHIN MINUTES" AFTER THE START OF DELIVERY, A LEAK OF SOLUTION WAS NOTED COMING FROM THE FILTER OF THE EXTENSION SET. THE NURSE REPORTED A "CRACK" NEAR THE OUTLET PORT OF THE FILTER AND BLEED BACK WAS NOTED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. 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 62 YR UNSPECIFIED PLUMSET, LIST# UNK, LOT# UNK