BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDHP 0.2 MICRN HP CL

    MDR report key: 2062302 · Received March 18, 2011

    Report

    Report Number
    9613251-2011-00029
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 3, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 INFORMATION 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; SUBSEQUENTLY, BLEED BACK WAS NOTED. THE TUBING SET WAS CONNECTED TO AN UNSPECIFIED PRIMARY TUBING SET AND WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF (B)(4) (A RESEARCH CHEMOTHERAPY MEDICATION) WITH A VOLUME TO BE INFUSED OF 500ML, AT A RATE OF 500ML/HR VIA A SIGMA SPECTRUM PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED AN UNSPECIFIED VOLUME OF SOLUTION WAS LEAKING FROM ONE OF THE TWO AIR VENTS ON THE FILTER AND BLEED BACK WAS NOTED IN THE TUBING. THE SOLUTION THAT LEAKED WAS CLEANED UP ACCORDING TO THE USER FACILITY¿S PROTOCOL. THE TUBING SETS AND SOLUTION CONTAINER WERE REPLACED AND THE THERAPY 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 910584W

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR