BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2251702 · Received August 31, 2011

    Report

    Report Number
    9616066-2011-00523
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K894842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER COMPLAINT OF PIN HOLE IN IV SET COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. CUSTOMER INDICATED THAT THE SET WAS NOT SAVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LEAK IN A SET. THE CUSTOMER STATED THAT THERE WAS A PIN HOLE IN THE SET THAT SPRAYED BLOOD ONTO A NURSE, IN HER FACE, ACROSS HER EYES. AS A RESULT, THE NURSE HAD AN EYE WASH. THE LEAK WAS REPORTED TO BE ABOVE THE SILICONE SEGMENT BUT BELOW THE DRIP CHAMBER. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION REQUIRED. CUSTOMER STATED THAT NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    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 73 YR