BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2123487 · Received June 8, 2011

    Report

    Report Number
    9616066-2011-00301
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS EVALUATED AND CUSTOMER'S COMPLAINT OF A LEAK AT THE UPPER SILICONE SEGMENT WAS CONFIRMED. A CRUSH MARK WAS SEEN ON THE UPPER FITMENT AND A TEAR WAS OBSERVED IN THE SILICONE TUBING AT THE UPPER FITMENT. THE ROOT CAUSE OF THE TEAR IN THE SILICONE TUBING AT THE UPPER FITMENT IS UNKNOWN.

    Description of Event or Problem · 1

    BIOMED REPORTED AN ADMINISTRATION SET LEAKED FROM A HOLE IN THE SILICONE SEGMENT BELOW THE UPPER FITMENT AND BLOOD LEAKED INTO THE PUMP. BIOMED BELIEVES THE BLOOD SET MAY HAVE BEEN MIS-LOADED AS THE TUBING LOOKS AS THOUGH IT WAS PINCHED IN THE DOOR. NO PATIENT HARM OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 10015414 UNK

    Patients

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