BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2230928 · Received July 20, 2011

    Report

    Report Number
    9616066-2011-00414
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RECEIVED AND AN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    RECEIVED REPORT THAT SALINE LEAKED FROM A HOLE IN THE PUMP SEGMENT. THE SET HAD BEEN IN USE FOR LESS THAN 72 HOURS. THE USER REMOVED THE SET AND NOTICED A HOLE ABOVE THE BLUE PIECE THAT ANCHORS THE SET TO THE PUMP. NO PATIENT HARM OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION UNKNOWN UNKNOWN

    Patients

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