BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF PP PRIM SYM SET PGB W/BCKCK V 2 CL

    MDR report key: 2181077 · Received July 7, 2011

    Report

    Report Number
    9615050-2011-00496
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 14, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K103344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. A DEVICE FROM ONE OF TWO POSSIBLE LOT NUMBERS (911685H AND 931315H) 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 BACKFLOW OF FLUID FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION AT AN UNSPECIFIED RATE VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME ON (B)(6) 2011, THE MALE ADAPTER OF AN UNSPECIFIED SECONDARY TUBING SET WAS CONNECTED TO THE PROXIMAL CLAVE Y-SITE ON THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF (B)(6) AT AN UNSPECIFIED RATE. IT WAS REPORTED THAT THE MEDICATION WAS DELIVERED. AT AN UNSPECIFIED TIME ON (B)(6) 2011, THE MALE ADAPTER OF AN UNSPECIFIED SECONDARY TUBING SET WAS CONNECTED TO THE PREVIOUSLY ACCESSED CLAVE Y-SITE ON THE PRIMARY TUBING SET FOR A SECOND PIGGYBACK DELIVERY OF AN UNSPECIFIED CONCENTRATION OF (B)(6) AT AN UNSPECIFIED RATE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED BACKFLOW OF AN UNSPECIFIED VOLUME OF SOLUTION FROM THE SECONDARY SOLUTION CONTAINER INTO THE PRIMARY SOLUTION CONTAINER. THE PHYSICIAN WAS NOTIFIED. THE DELIVERY OF MEDICATION WAS DISCONTINUED. 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 PP PRIM SYM SET PGB W/BCKCK V 2 CL 80FPA FPA HOSPIRA COSTA RICA LTD. NA PLOTS5H

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR UNSPECIFIED SECONDARY TUBING SET: LIST #UNK,| LOT #UNK| SYMBIQ PUMP: LIST #UNK, SN UNK