BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL

    MDR report key: 980006 · Received November 19, 2007

    Report

    Report Number
    9615050-2007-00130
    Event Type
    Malfunction
    Date Received
    November 19, 2007
    Date of Event
    October 18, 2007
    Report Date
    October 26, 2007
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K912103
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH RECEIVED THAT STATED: "THE RN NOTED A BLOOD LEAKING FROM THE IV TUBING. THE NURSING STAFF PRIMED THE IV TUBING WITH D5.45 W/20 EMQ KCL. NO LEAKING OR DIFFICULTY PRIMING THE TUBING. THE IV WAS INSERTED WITHOUT DIFFICULTY OR INCIDENT. THE RN THEN ATTACHED THE TUBING TO THE IV CATHETER AND BEGAN TO PROGRAM THE IV PUMP. THIS IS WHEN SHE NOTED FLOOD WAS BACKING UP IN THE IV LINE. THE RN CONFIRMED IT WAS A VENOUS LINE PLACEMENT, NOT ARTERIAL. FURTHER INSPECTION REVEALED AN APPROXIMATE 1MM HOLE, 12 INCHES UP FROM THE DISTAL BLUE CLAVE ON THE TUBING. THE EDGES OF THE HOLE APPEAR TO PUSH OUTWARD, GIVING THE IMPRESSION THAT SOMETHING BURST FROM THE INSIDE OF THE TUBING OUTWARD. THE TUBING WAS CHANGED. THE ESTIMATED BLOOD LOSS WAS 30CC. THERE WAS NO PT HARM. THE STAFF REPORTED THAT THE TUBING WAS NOT PINCHED OR CLAMPED FROM THE TIME IT WAS PRIMED TO WHEN THE EVENT OCCURRED. NO SHARPS CAME IN CONTACT WITH THE TUBING AND THE ROLLER CLAMP WAS NOT NEAR THE AREA THAT HAD THE HOLE. THE STAFF REPORTED THAT THEY HAVE NOT HAD THIS EXPERIENCE WITH THIS IV EQUIPMENT BEFORE. NO PACKAGING WAS SAVED; HOWEVER, THE MFR HAS BEEN CONTACTED AND WE ARE RETURNING THE DEVICE TO THEM." UPON FURTHER QUERY THE FOLLOWING INFO INDICATED A HOLE IN THE TUBING SET WITH SUBSEQUENT BLOOD LOSS. THE HOLE WAS LOCATED BETWEEN THE CASSETTE & THE CLAVE Y-SITE, 12 INCHES PROXIMAL TO THE Y-SITE. THE CUSTOMER ESTIMATED 30ML OF BLOOD WAS LOST. THE TUBING SET WAS REPLACED & THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL 90-FPA FPA HOSPIRA DE COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR