BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2140554 · Received June 15, 2011

    Report

    Report Number
    9616066-2011-00321
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: (B)(4), 2011. (B)(4). PRODUCT EVALUATED AND CUSTOMER'S REPORT OF A LEAKING SET WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED SET SHOWED A TEAR IN THE SILICONE TUBING BELOW THE UPPER FITMENT AND A CRUSH MARK WAS ALSO OBSERVED ON THE UPPER FITMENT. ROOT CAUSE OF THE TEAR WAS NOT IDENTIFIED. ALTHOUGH LOT NUMBER UNK, THE SMARTSITE LASER NUMBER INDICATES THIS SET WAS BUILT BETWEEN (B)(6) 2011 AND (B)(6) 2011. THE EXPIRATION DATE WOULD BE BETWEEN (B)(6) 2014 AND (B)(6) 2014.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SET LEAKED BENEATH THE UPPER FITMENT. SHE FOUND FLUID LEAKING OUT OF THE BOTTOM OF THE PUMP. NO PT HARM OR MEDICAL INTERVENTION REQUIRED. NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, S/N UNK| ALARIS PUMP MODULE, S/N UNK