BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIM SYM SET 2 CL

    MDR report key: 2915282 · Received January 9, 2013

    Report

    Report Number
    9615050-2013-00053
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 19, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K110901
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WERE DISCARDED. A REPRESENTATIVE DEVICE FROM AN UNSPECIFIED LOT 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

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF BACKFLOW OF FLUID FROM THE SECONDARY SOLUTION CONTAINERS INTO THE DRIP CHAMBERS OF THE PRIMARY TUBING SETS. ON UNSPECIFIED DATES, THE PRIMARY TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS VIA SYMBIQ PUMPS. AT UNSPECIFIED TIME, THE MALE ADAPTERS OF UNSPECIFIED SECONDARY TUBING SETS WERE CONNECTED TO THE PROXIMAL CLAVE Y-SITES OF THE PRIMARY TUBING SETS FOR A PIGGYBACK DELIVERIES OF UNSPECIFIED MEDICATIONS. AFTER UNSPECIFIED LENGTHS OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE NURSES NOTED BACKFLOW OF SOLUTION FROM THE SECONDARY SOLUTION CONTAINERS INTO THE DRIP CHAMBERS OF THE PRIMARY TUBING SETS. 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, INCLUDING IF THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13160 PRIM SYM SET 2 CL 80FPA FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED SYMBIQ PUMPS, LIST #UNK, LOT# UNK| UNSPECIFIED SECONDARY TUBING SET, LIST #UNK| LOT #UNK