BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2083364 · Received April 27, 2011

    Report

    Report Number
    9616066-2011-00171
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 20, 2011
    Report Date
    April 6, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REPORT DATE: APRIL 27, 2011. (B)(4). THE AFFECTED DEVICE HAS BEEN REC'D BUT HAS NOT YET BEEN EVALUATED. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER MEDWATCH REPORTED THE FOLLOWING: "THE PT IS A (B)(6) YEAR OLD, DOB (B)(6), FEMALE ADMITTED TO THE MED CTR ON (B)(6) 2011 FOR TREATMENT ASSOCIATED WITH A 40% TOTAL BODY SURFACE BURN. ON (B)(6) 2011, BLOOD CULTURES DRAWN WERE POSITIVE FOR E-COLI AND IV ANTIBIOTIC TREATMENT WAS ORDERED; CEFAZOLIN 2000 MG EVERY 8 HOURS. NEW IV TUBING WAS HUNG ON (B)(6) 2011. ON (B)(6) 2011, STAFF NOTICED THAT ALTHOUGH THE MEDICATION WAS FLOWING FROM SECONDARY SET AS IT SHOULD WITH APPROPRIATE SETUP, IT WAS FLOWING INTO THE IV MAINTENANCE BAG RATHER THAN INFUSING THROUGH THE ALARIS PUMP AND INTO THE PT. IV PUMP WAS REPLACED AND THE SAME PROBLEM STILL EXISTED. NEXT STAFF REPLACED THE IV SET WITH A NEW SET OF TUBING AND THE MEDICATION WAS DELIVERED AS ORDERED. STAFF FELT LIKE THE PROBLEM WAS WITH THE IV TUBING SET POSSIBLY AN ISSUE WITH THE BACK CHECK VALVE THAT SUPPOSE TO PREVENT FLUID FROM A SECONDARY BAG FROM FLOWING INTO A PRIMARY BAG." NO HARM TO THE PT WAS REPORTED AND NO MED INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 10015489 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR ALARIS PUMP MODULE: S/N UNK| ALARIS PC UNIT: S/N UNK