BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 2251708 · Received August 31, 2011

    Report

    Report Number
    9616066-2011-00517
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Report Date
    August 15, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK FROM THE FILTER. CUSTOMER DESCRIBES THE LEAK AS A "PINHOLE" IN THE FILTER BODY (SPECIFIC LOCATION NOT KNOWN). THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, THE CUSTOMER HAS NOT PROVIDED ANY FURTHER PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS EXTENSION SET FPA CAREFUSION CORP. 20129E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK