BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS EXTENSION SET

    MDR report key: 2222385 · Received July 15, 2011

    Report

    Report Number
    9616066-2011-00369
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 20, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K083472
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). . VISUAL EXAMINATION OF RETURNED SET SHOWED THE PISTON WAS SECURELY IN PLACE, THERE WERE NO TEARS AND THE HOUSING WAS INTACT WITHOUT EVIDENCE OF CRACKS OR CRAZING. THE TUBING AND MALE LUER SHOWED NO CRACKS, LEAKS, CAPILLARIES OR OTHER ANOMALIES. FUNCTIONAL TESTING WAS PERFORMED AND NO LEAKS WERE OBSERVED, HOWEVER, A SMALL DROPLET OF WATER WAS OBSERVED ON THE PISTON. THE CUSTOMER'S REPORT OF A LEAK WAS NOT CONFIRMED, THE RESIDUAL DROPLET THAT WAS OBSERVED AFTER DISCONNECTION IS A NORMAL FEATURE OF THE SET AND NOT A MALFUNCTION. THE CUSTOMER'S REPORT OF A LEAK IS NOT CONFIRMED. THE ROOT CAUSE OF THE OBSERVED DROPLET WAS THE EXPECTED RESIDUAL FLUID FROM THE SYRINGE TIP THAT IS LEFT BEHIND UPON DISCONNECT.

    Description of Event or Problem · 1

    IV THERAPY NURSE REPORTED EXTENSION SET LEAKING AT THE TOP OF THE MAXPLUS CONNECTOR AT THE VALVE BLUE SEPTUM. CUSTOMER STATED "THE SEPTUM IS NOT STUCK IN AND APPEARS TO BE IN THE NORMAL POSITION". NO PT HARM OR MEDICAL INTERVENTION REQUIRED. NO FURTHER EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXPLUS EXTENSION SET FPA CAREFUSION CORPORATION MP5302-C 11048007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK