BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ TRIPLE REFUR

    MDR report key: 4110531 · Received September 16, 2014

    Report

    Report Number
    9615050-2014-05244
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. IF THE DEVICE IS IDENTIFIED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE DEVICE WAS FOUND DELIVERING AT A RATE DIFFERENT THAN THE ORIGINALLY PROGRAMMED RATE RESULTING IN THE PATIENT RECEIVING MORE MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME, THE NURSE REPORTED THE DEVICE WAS PROGRAMMED TO DELIVER PITOCIN INDUCT/AUG 30U/500ML, STANDARD PROGRAM, WITH A DOSE OF 10MU/MIN, A 500ML VTBI (VOLUME TO BE INFUSED), A RATE OF 8ML/HR AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THE NURSE RETURNED TO THE PATIENT¿S ROOM AND NOTED THE DEVICE WAS DELIVERING AT A RATE OF 84ML/HR; HOWEVER, THE DISPLAY SHOWED THAT THE DEVICE WAS PROGRAMMED TO DELIVER 8MILLIUNITS/MIN. AT 0904. THE DELIVERY WAS STOPPED, THE PROGRAM WAS CLEARED AND THE DEVICE WAS REPROGRAMMED TO DELIVER AT A DOSE OF 10MU/MIN, A VTBI OF 500ML AND A RATE OF 10ML/HR AND THE DELIVERY WAS RESUMED. AT 0943, THE NURSE RETURNED TO THE ROOM AND REPORTED THE DEVICE WAS NOTED TO BE DELIVERING AT A RATE OF 84ML/HR. IT WAS REPORTED THE CONTAINER WAS EMPTY. IT WAS NOT SPECIFIED THE VOLUME EXPECTED TO BE REMAINING IN THE CONTAINER. THE DEVICE WAS POWERED OFF AND PUT IN THE HALL. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. NO PROGRAMMING PARAMETERS WERE PROVIDED. THE DEVICE WAS NOT ISOLATED AT THE TIME OF THE EVENT. THERE WERE NO ADVERSE EFFECTS OR NEED FOR MEDICAL INTERVENTION. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574162 PLUM A+ TRIPLE REFUR 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1