BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMSET-DUAL W/CON PP, CAP PORT & CLAVE

    MDR report key: 1170789 · Received September 15, 2008

    Report

    Report Number
    9615050-2008-00266
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 20, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K953584
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. A REPRESENTATIVE DEVICE FROM ONE OF TWO POSSIBLE LOT NUMBERS 652015H AND 650865H 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 HOSPITAL PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A TUBING SEPARATION. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED AMOUNT OF INTRAVENOUS IMMUNOGLOBULIN (IVIES) VIA A PLUM PUMP. IT WAS REPORTED THAT 2 HOURS AFTER THE DELIVERY WAS STARTED, THE PUMP SOUNDED AN AUDIBLE ALARM. AT THIS TIME, THE NURSE NOTICED THAT THE TUBING HAD SEPARATED FROM THE DISTAL END OF THE CASSETTE. THE TUBING SET WAS REPLACED AND THE THERAPY WAS COMPLETED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUMSET-DUAL W/CON PP, CAP PORT & CLAVE 80-FPA FPA HOSPIRA DE COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK