BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECNDRY SET 34IN NDEHP

    MDR report key: 2191099 · Received July 25, 2011

    Report

    Report Number
    9613251-2011-00162
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 27, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE TUBING SET DID NOT DELIVER. A PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED TIME, VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTOR OF THE TUBING SET WAS CONNECTED TO AN UNSPECIFIED LOCATION ON THE PRIMARY TUBING SET. THE TUBING SET WAS BEING USED FOR A PIGGYBACK DELIVERY, OF AN UNSPECIFIED ANTIBIOTIC, AT A RATE OF 100 ML/HR. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED THAT THE SECONDARY MEDICATION DID NOT DELIVER. IT WAS REPORTED THAT THE NURSE "HAD TO CLAMP THE PRIMARY LINE TO INFUSE THE SECONDARY BECAUSE IT KEPT INFUSING THE PRIMARY LINE INSTEAD OF THE SECONDARY." 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 ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECNDRY SET 34IN NDEHP 80FPK FPK HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 SYMBIQ PRIMARY TUBING SET: LIST# 16120, LOT# UNK