BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1156723 · Received August 29, 2008

    Report

    Report Number
    2016493-2008-00137
    Event Type
    Other
    Date Received
    August 29, 2008
    Date of Event
    January 29, 2007
    Report Date
    February 6, 2007
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER REVIEW OF OUR QUALITY SYSTEM, SPECIFICALLY REPORTABLE ADVERSE EVENT CRITERIA, WE REDEFINED OUR CRITERIA FOR A REPORTABLE EVENT CONSISTENT WITH 21 CFR PART 803 MEDICAL DEVICE REPORTING REQUIREMENTS. BASED ON A 2-YR RETROSPECTIVE AUDIT UTILIZING THE NEW CRITERIA, THESE EVENTS ARE NOW DEEMED REPORTABLE. THIS REPORT INCLUDES A TOTAL OF INFUSION INACCURACY EVENTS REPORTED TO US BETWEEN 2006 THROUGH 2008. THESE EVENTS DID NOT RESULT IN ANY SERIOUS INJURY, HARM OR DEATH, NOR WERE EVENTS CONSIDERED NEW OR UNUSUAL. THE INVESTIGATION OF THESE REPORTS CONCLUDED THE MAJORITY OF COMPLAINTS WERE DUE TO USE ERRORS, PROGRAMMING ERRORS OR NO CONCLUSION FOR THOSE DEVICES NOT RETURNED FOR INVESTIGATION. ALL DEVICES RETURNED WERE OPERATING WITHIN SPECIFICATIONS. THIS REPORT COVERS: REPORTS ON 8000 FRN PUMP, INFUSION; REPORTS ON 8015 FRN PUMP, INFUSION; REPORTS ON 8100 FRN PUMP, INFUSION; REPORTS ON 8110 FRN PUMP, INFUSION; REPORTS ON 8120 MEA, PCA INFUSION PUMP; 1 REPORT ON 1320 FRN PUMP, INFUSION; 1 REPORT ON 1325 FRN PUMP, INFUSION; REPORTS ON 7130 FRN PUMP, INFUSION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POSSIBLE OVERINFUSION OF PITOCIN AND REQUESTED AN EVENT LOG REVIEW OF PROGRAMMING KEY PRESSES. EVENT LOG REVIEW INDICATED THE PT WAS ON MULTIPLE INFUSIONS. PITOCIN INFUSION STARTED AT 14:53 AT RATE OF 6ML/H WITH A VTBI OF 450ML. ANOTHER INFUSION DEVICE WAS INFUSING LACTATED RINGERS AT RATE OF 125ML/H WITH VTBI OF 450ML WITH A SECONDARY INFUSION OF AMPICILLIN AT RATE OF 200ML/H AND VTBI OF 100ML. THE DEVICE INFUSING THE PITOCIN HAD MULTIPLE DOSE CHANGES UNTIL 19:20 WHEN THE USER CHANGED THE RATE TO 36ML/H. THE DEVICE DISPLAYED A GUARDRAIL ALERT, DOSE ABOVE MAXIMUM. USER CONFIRMED ALERT AND PROCEEDED TO START THE INFUSION. THE INFUSION CONTINUED UNTIL 19:35 WHEN THE DEVICE WAS POWERED OFF. THERE WAS NO REPORTED INJURY OR HARM TO PT OR FETUS. FOLLOWING EVENT LOG REVIEW, THE CONCLUSION WAS THE OVERINFUSION WAS DUE TO A PROGRAMMING ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM PUMP MODULE FRN PUMP, INFUSION FRN CARDINAL HEALTH ALARIS PRODUCTS 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other