BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2962007 · Received January 23, 2013

    Report

    Report Number
    9616066-2013-00050
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 24, 2012
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT IT HAS NOT BEEN EVALUATED YET. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A LEAK OCCURRED DURING AN ARA-C CHEMOTHERAPY INFUSION WHICH RAN FOR OVER 1 HOUR. THE LEAK WAS NOT NOTICED UNTIL AFTER THE TUBING HAD BEEN PUT INTO THE BIN FOR CHEMOTHERAPY WASTE. THE SET WAS RETRIEVED FROM THE CHEMO BIN AND A SMALL TEAR WAS NOTED IN THE TUBING ABOVE THE BOTTOM PORT. THE TEAR WAS DESCRIBED AS A CUT, ABOUT 1/4" LONG, IN THE TUBING APPROXIMATELY 12" FROM THE DISTAL END AND THAT IT APPEARED THAT IT COULD HAVE BEEN CAUSED BY A BOX-CUTTER OR OTHER SHARP INSTRUMENT. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION. CUSTOMER STATED THAT NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32244 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP. 2110-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR