BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF MIF MAC EXT (CAS/48)

    MDR report key: 4253339 · Received November 12, 2014

    Report

    Report Number
    9613251-2014-00154
    Event Type
    Malfunction
    Date Received
    November 12, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 23, 2014
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. 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 SEPARATION. THE SECURE LOCK MALE ADAPTER WAS CONNECTED TO THE FEMALE ADAPTER OF A PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE AND WAS DELIVERING 11MG OF GENTAMYCIN, AT AN UNSPECIFIED RATE, VIA A PUMP. AT AN UNSPECIFIED TIME, AN UNSPECIFIED TUBING SET WAS CONNECTED TO THE CLAVE Y-SITE ON THE EXTENSION TUBING SET AND WAS BEING USED TO DELIVER 10% DEXTROSE AT A RATE OF 1ML/HR TO KEEP THE PICC LINE OPEN. AT 1517, THE CUSTOMER CONTACT REPORTED THAT APPROXIMATELY 0.3 ML OF BLEED BACK WAS NOTED IN THE TUBING SET. IT WAS REPORTED THAT THE CLINICIAN ATTEMPTED TO FLUSH THE TUBING SET; HOWEVER, THE TU BING WAS CLOTTED AND THE PICC LINE WAS DISCONTINUED. AT THAT TIME, IT WAS REPORTED THAT A SEPARATION OF THE DISTAL TUBING FROM THE FILTER OF THE TUBING SET WAS NOTED. IT WAS REPORTED THAT THE COMPLETION OF THE GENTAMYCIN WAS DELAYED BY AN HOUR DUE TO OBTAINING A NEW IV ACCESS SITE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF CRITICAL THERAPY TO THE PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729629 LS LF MIF MAC EXT (CAS/48) 80FPA FPA HOSPIRA LTD. NA 241814W

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED TUBING SET, LIST #UNK, MFR: UNK