BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2891043 · Received November 14, 2012

    Report

    Report Number
    9616066-2012-00800
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 26, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT IT HAS NOT BEEN EVALUATED YET. A F/U 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 UPON ENTERING THE PT'S ROOM AT 1730, THE RN NOTED THE CHEMO BAG TO BE EMPTY (BAG #3/4). THE DOSE WAS NOT SCHEDULED TO COMPLETE UNTIL 2300. THE RATE OF CHEMO INFUSION WAS CORRECT; RATE OVER 24 HOURS WAS 20.8 ML/HR. THE CHEMO WAS A MIXTURE OF DOXORUBICIN, VINCRISTINE AND ETOPOSIDE AND THE PICC LINE WAS FLUSHED APPROPRIATELY (+BBR). THE CHEMO WAS SET-UP AS A SECONDARY INFUSION BUT PROGRAMMED AS A PRIMARY INFUSION. THERE WERE NO ADVERSE COMPLAINTS FROM THE PT AND MEDICAL INTERVENTION WAS NOT REQUIRED. THE DOCTOR WAS NOTIFIED WHO ADVISED TO CONTINUE MONITORING THE PT AND ADMINISTER THE NEXT DOSE OF CHEMO AT THE SCHEDULED TIME OF 2300. THE CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORP 2414-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR ALARIS PUMP MODULE (B)(4)| ALARIS PC UNIT SN (B)(4)| PICC LINE MFR/MODEL/LOT UNK