BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2851494 · Received October 31, 2012

    Report

    Report Number
    9616066-2012-00772
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SETS IN USE DURING THE REPORTED EVENT WERE DISCARDED. UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORT THAT THE SECONDARY BACKED UP INTO THE PRIMARY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SECONDARY MEDICATION BACKED UP INTO THE PRIMARY BAG. THE REPORTER STATED THE SET UP WAS CORRECT BUT THE BACK CHECK VALVE WAS NOT WORKING PROPERLY. IT WAS FURTHER REPORTED THAT THE BACK FLOW WAS VISIBLE BECAUSE THE SECONDARY MEDICATION WAS RED. THERE WAS NO PATIENT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL PATIENT OR EVENT INFORMATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2420-0007 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS SECONDARY ADMINISTRATION SET| ALARIS PC UNIT: SN UNK| ALARIS PUMP MODULE: SN UNK| MODEL 11448964, LOT UNK