BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM XL3M

    MDR report key: 115151 · Received August 22, 1997

    Report

    Report Number
    2921482-1997-00150
    Event Type
    Injury
    Date Received
    August 22, 1997
    Date of Event
    July 20, 1997
    Report Date
    July 21, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INITIALLY HELD DEVICE AT THEIR FACILITY AND HAD NOT DECIDED IF THEY WOULD FORWARD IT TO ABBOTT FOR TESTING. THEY LATER ELECTED TO RETURN PUMP FOR MFR TESTING AND IT WAS RECEIVED ON 12/17/1997. CO WAS UNABLE TO CONFIRM/DUPLICATE REPORTED PROBLEM WITH TESTING AND INVESTIGATION. UNIT WAS TESTED PER INFO RECEIVED FROM OUR MEDICAL DEPT INVESTIGATION AND OUR FIELD CLINICAL NURSE CONSULTANT INDICATING "SLIDE CLAMP STUCK INTO PUMP DOOR." CO SIMULATED ALL POSSIBLE WAYS OF HAVING CLAMP IN DOOR WHEN CLOSED, INCLUDING DIFFERENT CASSETTES. PUMP ALARMED "DOOR/CASSETTE" EVERY TIME AND WE WERE UNABLE TO START PUMP. NO FREE FLOW SITUATION WAS OBSERVED. UNIT PASSED PERFORMANCE VERIFICATION TESTING AND SHORT TERM AND LONG TERM DELIVERY ACCURACY TESTS. THE FREQUENCY OF DEATH OR SERIOUS INJURY REPORTS FOR CODE 102 (OVERDELIVERY) PLUM PRODUCT IS 0.59/MILLION SETS.

    Description of Event or Problem · 1

    OVERDELIVERY REPORTED. THE PUMP WAS SET AT APPROX. 2 PM TO INFUSE A 500 ML TPN SOLUTION AT 9 ML/HR ON CHANNEL B. AT 4 PM THE PUMP GAVE AN UNSPECIFIED ALARM AND THE NURSE NOTED THERE WAS APPROX. 25 ML REMAINING IN THE CONTAINER. THE DISPLAY INDICATED 19.4 ML HAD INFUSED. THE PT'S BLOOD GLUCOSE LEVEL WAS ELEVATED AND SERUM ELECTROLYTES WERE "OFF." PER PHYSICIAN ORDER, THE PT RECEIVED LASIX AND IV FLUIDS WERE HELD FOR APPROX. 5 HOURS. THE INFANT'S GLUCOSE AND ELECTROLYTE LEVELS WERE ALLOWED TO STABILIZE TO NORMAL LIMITS WITHOUT FURTHER INTERVENTION. NURSES REPORTED THAT NO RESIDUAL ADVERSE EFFECTS WERE OBSERVED. NO FURTHER PT INFO WAS AVAILABLE. THE NEONATAL ICU NURSE MGR REPORTS THAT THE EXPERIENCING NURSE NOTED THE GREEN SLIDE CLAMP OF THE IV TUBING (PROXIMAL TO THE CASSETTE) WAS STUCK IN THE PUMP DOOR IN SUCH A WAY THAT THE DOOR DID NOT CORRECTLY CLOSE AND FLUID FLOW WAS ALLOWED WITHOUT A DEVICE ALARM SOUNDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM XL3M INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DAY Required Intervention LIST NUMBER 19002| NON-VENTED PLUM IV PUMP SET, CUSTOM DESIGN