BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF MIF MAC EXT (CAS/48)

    MDR report key: 2503146 · Received March 20, 2012

    Report

    Report Number
    9613251-2012-00051
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    February 22, 2012
    Report Date
    February 12, 2012
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. 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; SUBSEQUENTLY BLEED BACK WAS NOTED. THE MALE ADAPTER OF AN UNSPECIFIED GEMSTAR PRIMARY TUBING SET WAS CONNECTED TO THE FEMALE ADAPTER OF THE EXTENSION TUBING SET. THE TUBING SETS WERE BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF TOTAL PARENTERAL NUTRITION, AT AN UNSPECIFIED RATE, VIA A GEMSTAR PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, SOLUTION LEAKED FROM THE LUER CONNECTION OF THE TUBING SETS. IT WAS REPORTED THAT BLEED BACK WAS NOTED DISTAL TO THE AIR ELIMINATING FILTER OF THE EXTENSION TUBING SET. THE TUBING SETS WERE REPLACED 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
    1 LS LF MIF MAC EXT (CAS/48) 80FPK FPK HOSPIRA LTD. NA UNK4W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LOT #UNK| UNSPECIFIED GEMSTAR PRIMARY TUBING SET: LIST #UNK,