BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2822094 · Received October 9, 2012

    Report

    Report Number
    9616066-2012-00715
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    September 23, 2012
    Report Date
    September 24, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER STATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE THE TUBING WAS DISCARDED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT LOPRESSOR WAS SET-UP AS A SECONDARY INFUSION. THE NURSE NOTICED IMMEDIATELY THAT THE LOPRESSOR APPEARED TO BE FREE-FLOWING IN THE DRIP CHAMBER AND NOTICED THAT IT WAS BACKING UP INTO THE PRIMARY BAG. THE NURSE CHANGED THE PRIMARY TUBING AT THAT POINT AND THEN ATTACHED THE PRIMED SECONDARY SET AND ADMINISTERED THE INFUSION WITHOUT ISSUES. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN UNKNOWN| ALARIS PUMP MODULE: SN UNKNOWN