BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NVPRM PB CLV OL100IN

    MDR report key: 2181048 · Received July 7, 2011

    Report

    Report Number
    9613251-2011-00148
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    HOSPIRA, LTD
    Product Code
    FPA
    PMA / PMN Number
    K030002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. A DEVICE FROM A POSSIBLE LOT NUMBER 021994W 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 DRIP CHAMBER OF THE PRIMARY TUBING SET. THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF NORMAL SALINE, AT A RATE OF 40ML/HR, VIA A PUMP. AT AN UNSPECIFIED TIME, 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 MAXIPIME IN 50ML, AT A RATE OF 100 ML/HR. THE PRIMARY SOLUTION CONTAINER WAS LOWERED BELOW THE SECONDARY SOLUTION CONTAINER. IT WAS REPORTED THAT IMMEDIATELY AFTER THE PIGGYBACK DELIVERY WAS STARTED, THE NURSE NOTED BACKFLOW OF SOLUTION INTO THE PRIMARY TUBING SET DRIP CHAMBER . THE PRIMARY TUBING WAS CLAMPED AND THE DELIVERY WAS STOPPED. THE SECONDARY TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. IT WAS REPORTED THAT AFTER THE DELIVERY WAS STARTED, THE NURSE AGAIN NOTED BACKFLOW OF SOLUTION INTO THE PRIMARY TUBING SET DRIP CHAMBER. THE DELIVERY WAS STOPPED. THE PRIMARY TUBING SET WAS THEN 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 NVPRM PB CLV OL100IN 80FPA FPA HOSPIRA, LTD NA PLOT4W

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT #UNK| UNSPECIFIED SECONDARY TUBING SET: LIST #UNK,| MFR SIGMA (B)(4)| SPECTRUM PUMP: MODEL 35700, SN UNK