BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N

    MDR report key: 1915368 · Received November 3, 2010

    Report

    Report Number
    9615050-2010-00219
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 8, 2010
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    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 IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN REC'D. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT SOLUTION FROM THE SECONDARY LINE BACKFLOWED INTO THE PRIMARY LINE. AT 1648, LINE A OF THE DEVICE WAS PROGRAMMED TO DELIVER 500ML OF D5 1/2 NORMAL SALINE AT A RATE OF 3ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 50ML, AND THE DELIVERY WAS STARTED. AT 1741, LINE B OF THE DEVICE WAS PROGRAMMED IN THE PIGGYBACK MODE TO DELIVER FLUCONAZOLE 240MG, AT A RATE OF 240ML/HR, WITH A VTBI OF 120ML, AND THE DELIVERY WAS STARTED. AT 1756, THE NURSE NOTED THAT THE DEVICE DISPLAY INDICATED THAT LINE B HAD DELIVERED 6.4ML; HOWEVER, THE FLUCONAZOLE CONTAINER WAS EMPTY. AT THIS TIME, IT WAS REPORTED THE 500ML D5 1/2 NORMAL SALINE CONTAINER WAS ENLARGED. THE PHYSICIAN WAS NOTIFIED. THE DEVICE, TUBING SET AND FLUCONAZOLE CONTAINER WERE REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE, TUBING SET AND FLUCONAZOLE CONTAINER. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLMA DVC V11.51 1 N 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR PLUM A+ SOFTWARE MODULE, LIST #20677,| SECONDARY TUBING SET, LIST #14230, LOT #UNK| (B)(4)| PLUMSET, LIST #12030, LOT #UNK