BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCLAIM ENCORE 2.25

    MDR report key: 2093227 · Received April 14, 2011

    Report

    Report Number
    9615050-2011-00252
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    December 3, 2010
    Report Date
    March 17, 2011
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K011096
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PATIENT RECEIVED LESS MEDICATION THAN INTENDED. IT WAS REPORTED THAT THE PUMP WAS BEING USED FOR BACK TO BACK DELIVERIES OF VANCOMYCIN 4.762MG/ML AND DORIBAX 5MG/ML; HOWEVER, THE CUSTOMER COULD NOT SPECIFY THE ORDER IN WHICH THE ANTIBIOTICS WERE TO BE DELIVERED. AT AN UNSPECIFIED TIME AFTER THE FIRST ANTIBIOTIC WAS DELIVERED, THE PUMP WAS REPROGRAMMED TO DELIVER THE SECOND UNSPECIFIED ANTIBIOTIC AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER REPORTED, "THE PUMP DID NOT INFUSE ALL. LEFT ABOUT 1/3 OF BAG." THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING GRAVITY FLOW. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THE CUSTOMER CONTACT REPORTED THAT THE EVENT MAY HAVE BEEN DUE TO A POSSIBLE USER ERROR IN REPROGRAMMING THE VTBI (VOLUME TO BE INFUSED) OF THE SECOND ANTIBIOTIC. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCLAIM ENCORE 2.25 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR