BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF MACR EXT ST (CAS/48)

    MDR report key: 3102706 · Received May 2, 2013

    Report

    Report Number
    9613251-2013-00117
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 5, 2013
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 A LEAK. AT AN UNSPECIFIED TIME, THE SECURE LOCK MALE ADAPTER OF THE PRIMARY TUBING SET WAS CONNECTED TO THE FEMALE ADAPTER OF THE EXTENSION TUBING SET AND WAS PRIMED VIA GRAVITY IN THE USER FACILITY TO DELIVER TOTAL PARENTERAL NUTRITION (TPN). THE CUSTOMER CONTACT REPORTED THAT THE TUBING SET WAS SLOW TO PRIME VIA GRAVITY. NO SPECIFIC DETAILS WERE PROVIDED. AT AN UNSPECIFIED TIME, THE TUBING SET WAS LOADED INTO A GEMSTAR PUMP AND THE PUMP WAS PROGRAMMED TO DELIVER TPN 1375 ML, AT A RATE OF 91 ML/HR, FOR A DURATION OF 12 HOURS. AFTER AN UNSPECIFIED LENGTH OF TIME, THE TUBING SET WAS CONNECTED TO THE PATIENT'S IV ACCESS SITE AND THE DELIVERY WAS STARTED. AT AN UNSPECIFIED TIME, THE PATIENT WENT HOME. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT'S HUSBAND REPORTED THAT AN UNSPECIFIED VOLUME OF SOLUTION LEAKED AT THE CONNECTION OF THE SECURE LOCK MALE ADAPTER AND THE FEMALE ADAPTER. REPORTEDLY AT THIS TIME, A 1.25 INCH SEGMENT OF AIR WAS NOTED DISTAL TO THE AIR ELIMINATING FILTER. NO AIR WAS DELIVERED TO THE PATIENT. THE TUBING SETS WERE REPLACED BY THE HOME HEALTH NURSE AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193384 LS LF MACR EXT ST (CAS/48) 80FPA FPA HOSPIRA LTD. NA 250974W

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR