BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM A+ DRIVER NEW 8

    MDR report key: 1579913 · Received January 13, 2010

    Report

    Report Number
    2921482-2010-00018
    Event Type
    Other
    Date Received
    January 13, 2010
    Date of Event
    November 28, 2009
    Report Date
    December 14, 2009
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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 INFORMATION 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 PATIENT RECEIVING MORE MEDICATION THAN INTENDED. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH A DIAGNOSIS OF ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE AND WAS PLACED ON A CARDIAC MONITOR. THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF CARDIZEM AT THE RATE OF 10ML/HR AND VTBI (VOLUME TO BE INFUSED) OF 100ML AND THE DELIVERY WAS STARTED. AFTER AN UNSPECIFIED LENGTH OF TIME, THE DEVICE ALARMED WITH AN UNSPECIFIED ALARM. AT THIS TIME THE PATIENT'S BP (BLOOD PRESSURE) HAD DECREASED TO 77/38MMGH AND HR (HEART RATE) DECREASED TO 52 BEATS PER MINUTE (BPM). AT THIS TIME, THE NURSE NOTED THE CARDIZEM CONTAINER WAS EMPTY AND THE RATE WAS DISPLAYED AS 100ML/HR. THE PHYSICIAN WAS NOTIFIED AND THE CARDIZEM WAS DISCONTINUED. NO FURTHER MEDICAL INTERVENTIONS WERE REQUIRED. IT WAS REPORTED THAT THREE HOURS LATER, THE PATIENT'S VITAL SIGNS WERE STABLE AND THE PATIENT WAS TRANSFERRED TO THE CCU (CARDIAC CARE UNIT). THE CUSTOMER CONTACT STATED THE EVENT WAS DUE TO "AN ERROR IN PROGRAMMING THE DEVICE AS THE DRUG LIBRARY WAS NOT USED WHICH CAUSED THE INCIDENT. THE DEVICE WAS PROGRAMMED AT A RATE OF 100ML/HR INSTEAD OF THE INTENDED RATE OF 10ML/HR, WHICH WAS VERIFIED." THE CUSTOMER CONTACT STATED THE NURSE RETROSPECTIVELY INDICATED THAT THE PUMP DID NOT RESPOND WHEN ATTEMPTING TO PROGRAM THE 10ML/HR RATE. REPORTEDLY, THE ONE APPEARED ON THE SCREEN, BUT THE ZERO DID NOT, SO ZERO WAS ENTERED AGAIN. THOUGH REQUESTED, NO ADDITIONAL INFORMATION 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 83 YR Required Intervention SN UNK| CARDIZEM, MANUFACTURED BY BEDFORD| PLUM A+ SOFWARE MODULE| LIST#20791