BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM A+ PUMP

    MDR report key: 675773 · Received January 31, 2006

    Report

    Report Number
    2921482-2006-00739
    Event Type
    Other
    Date Received
    January 31, 2006
    Date of Event
    October 18, 2005
    Report Date
    January 5, 2006
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT RECEIVED MORE MEDICATION THAN INTENDED. THE REPORT STATED, "HEPARIN 25,000 UNITS IN 250CC D5W PROGRAMMED TO RUN AT 9.2CC/HOURS. PUMP ALARMED STATING RATED OF 1CC-VOLUME EMPTY. BAG WAS FULL. VOLUME ADJUSTED TO 200CC. ONE HOUR LATER 200CC HAD INFUSED. RATE 0.VOLUME 440. PATIENT MONITORED FOR EVEVATED PTT. TEMP HARM-NO INTERVENTION REQUIRED. PUMP REMOVED FROM SERVICE AND SENT TO CLINICAL ENGINEERING." UPON FURTHER QUERY THE FOLLOWING INFORMATION WAS PROVIDED: THE CUSTOMER CONTACT REPORTED AN OPERATOR ERROR IN PROGRAMMING THE DEVICE, WHICH RESULTED IN THE PT RECEIVING MORE MEDICATION THAN INTENDED. AT AN UNSPECIFIED TIME THE PUMP WAS PROGRAMMED TO DELIVER HEPARIN (25,000U/250D5W) AT A RATE OF 9.2ML/HR AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OT TIME, THE PUMP SOUNDED AN USPECIFIED AUDIBLE ALARM. THE RN NOTED THE PUMP DISPLAYED A RATE OF 1ML/HR AND A VOLUME TO BE INFUSED (VTBI) OF 0; HOWEVER, THE HEPARIN BAG WAS STILL FULL. THE PUMP WAS THEN REPROGRAMMED WITH A VTBI OF 200ML. APPROXIMATELY ONE HOUR LATER, THE RN NOTED 200ML OF HEPARIN HAD INFUSED. REPORTEDLY, THE RN INADVERTENTLY PROGRAMMED THE RATE WITH THE VTBI. THE PHYSICIAN WAS NOTIFIED AND A PTT LEVEL WAS DRAWN. NO MEDICAL INTERVENTIONS WERE REQUIRED. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. DURING TESTING AT THE USER FACILITY, THE PUMP PASSED TESTING FOR DELIVERY ACCURACY. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ PUMP INFUSION PUMP FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other