BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM A+ DRIVER NEW 8

    MDR report key: 1612052 · Received February 18, 2010

    Report

    Report Number
    2921482-2010-00061
    Event Type
    Other
    Date Received
    February 18, 2010
    Date of Event
    January 20, 2010
    Report Date
    January 21, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT ISOLATED OR IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL; (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PT RECEIVING MORE MEDICATION THAN INTENDED. THE PT WAS BEING TREATED IN THE ER WITH A DIAGNOSIS OF CHEST PAIN AND WAS SCHEDULED FOR A CARDIAC CATHETERIZATION. AT 0135, THE DEVICE WAS PROGRAMMED IN THE ML/HR MODE, TO DELIVER HEPARIN 100UNITS/ML, FOR A DOSE OF 768 UNITS/HR, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER APPROX 10 MINUTES, THE NURSE NOTED THE HEPARIN CONTAINER "APPEARED MORE EMPTY THAN EXPECTED." AT THIS TIME, THE NURSE NOTED THE DEVICE HAD BEEN PROGRAMMED TO DELIVER AT A RATE OF 768 ML/HR (76800 UNITS/HR) INSTEAD OF THE INTENDED DOSE OF 768 UNITS/HR. THE PHYSICIAN WAS NOTIFIED AND ORDERED AN APTT (ACTIVATED PARTIAL THROMBOPLASTIN TIME) LEVEL TO BE DRAWN. THE DEVICE WAS NOT REMOVED FROM CLINICAL SERVICE. THE HEPARIN THERAPY WAS DISCONTINUED. NO FURTHER MEDICAL INTERVENTIONS WERE REQUIRED. THE CUSTOMER CONTACT STATED THE PT HAS "FULLY RECOVERED FROM THE EVENT." ALTHOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ DRIVER NEW 8 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention HEPARIN, MFR HOSPIRA, INC.| PLUM A+ SOFTWARE MODULE, LIST #20791, SN UNK