BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 1935415 · Received December 15, 2010

    Report

    Report Number
    9616066-2010-00365
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 29, 2010
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 12/15/2010. (B)(4). THIS REPORT WAS FILED BY THE MFR. PRODUCT EVALUATED AND CUSTOMER'S REPORT THAT THE TUBING SEPARATED AND LEAKED BELOW THE LOWER FITMENT WAS CONFIRMED. NO CRUSH MARKS OR DAMAGES WERE FOUND ON THE TUBING OR LOWER FITMENT. A DIMENSIONAL EVAL OF THE COMPONENTS VERIFIED THE COMPONENTS WERE WITHIN SPECIFICATION. TRACES OF SOLVENT WERE OBSERVED ON THE TUBING AND LOWER FITMENT. THE ROOT CAUSE OF THE SEPARATION AND LEAK BELOW THE LOWER FITMENT WAS IDENTIFIED AS INSUFFICIENT SOLVENT APPLICATION TO THE TUBING AND LOWER FITMENT ENGAGEMENT. MFR DATE IDENTIFIED BY SMARTSITE VALVE LASER NUMBER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE IV TUBING WAS SEVERED BELOW THE LOWER FITMENT, AROUND THE SAFETY CLAMP AREA, RESULTING IN A LEAK. WHEN THE TUBING SEPARATED, THE END CONNECTED TO THE PT'S CENTRAL LINE, FELL TO THE FLOOR, AND THE PT'S BLOOD LEAKED OUT. NO PT HARM REPORTED OR MEDICAL INTERVENTION REQUIRED. NO ADDITIONAL EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2426-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR ALARIS PUMP MODULE, SERIAL NUMBER UNK| ALARIS PC UNIT, SERIAL NUMBER UNK