BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDHP LS MICROB CLAVE

    MDR report key: 3172427 · Received June 5, 2013

    Report

    Report Number
    9613251-2013-00167
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    February 1, 2013
    Report Date
    May 14, 2013
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THE DEVICES ARE DISCARDED. HOSPIRA HAS COMPLETED A FORMAL INVESTIGATION TO ADDRESS THE ISSUE OF SEPARATION OF THE CLAVE PORT FROM THE SEMI-RIGID ADAPTER. BASED ON THE INVESTIGATION RESULTS, THE MOST PROBABLE CAUSE OF THE SEPARATION WAS DUE TO INSUFFICIENT SOLVENT APPLICATION. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF SEPARATIONS. ON UNSPECIFIED DATES, THE OPTION-LOK MALE ADAPTER OF PRIMARY PLUMSETS WAS CONNECTED TO THE CLAVE PORT OF THE EXTENSION TUBING SETS AND WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS, AT UNSPECIFIED RATES, VIA PLUM PUMPS. THE SPIN-LOC MALE ADAPTER OF THE EXTENSION TUBING SETS WERE CONNECTED TO THE PTS' IV ACCESS SITES. AFTER UNSPECIFIED LENGTHS OF TIME, IT WAS REPORTED THAT THE CLAVE PORT SEPARATED FROM THE SEMI-RIGID FEMALE ADAPTER OF THE EXTENSION TUBING SETS AND UNSPECIFIED VOLUMES OF SOLUTIONS LEAKED. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAYS IN THERAPIES CRITICAL TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249586 NDHP LS MICROB CLAVE 80FPA FPA HOSPIRA LTD. NA UNKS

    Patients

    Seq Age Sex Outcome Treatment
    1 PRIMARY PLUMSETS, LIST #14242, LOT # UNK