BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM SET 2 CL

    MDR report key: 3964059 · Received May 5, 2014

    Report

    Report Number
    9615050-2014-03214
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 10, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K103344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS RECEIVED AND EVALUATED. TESTING FOUND THE TUBING SEPARATED FROM THE OUTLET PORT OF THE CASSETTE OF THE TUBING SET. THIS WAS DUE TO INSUFFICIENT SOLVENT APPLICATION. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER CONTACT IDENTIFIED TWO POSSIBLE LOT NUMBERS. THE POSSIBLE LOT NUMBERS ARE 300295H AND 321505H. 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 TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE, AT A RATE OF 40ML/HR, VIA A SYMBIQ PUMP. THE CUSTOMER CONTACT REPORTED THAT LESS THAN AN HOUR AFTER THE INFUSION WAS STARTED, THE NURSE NOTED THAT SOLUTION LEAKED AND A SMALL AMOUNT OF BLOOD ON THE PATIENT AND PATIENT'S BED. AT THAT TIME, IT WAS NOTED THAT THE TUBING SEPARATED FROM THE OUTLET PORT OF THE CASSETTE. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. IN ADDITION, THE PATIENT'S IV CATHETER HAD CLOTTED AND A NEW PERIPHERAL IV WAS STARTED. THERE WERE NO REPORTS OF ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY IN THERAPY CRITICAL TO THE PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268349 PRIM SYM SET 2 CL 80FRN FRN HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED IV CATHETER, LIST#UNK, MFR UNK