BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALARIS SYSTEM PUMP MODULE

    MDR report key: 1033544 · Received April 23, 2008

    Report

    Report Number
    2016493-2008-00023
    Event Type
    Other
    Date Received
    April 23, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 31, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATA REC'D FROM THE LVP EVENT LOG FOR THE DATE IN QUESTION INDICATES THAT THE INFUSION WAS SET UP IN THE MORNING AND RAN FOR A TOTAL OF 26 MINS BEFORE BEING STOPPED. LATER IN THE AFTERNOON, THE INFUSION WAS RESTARTED AND RAN FOR A SHORT PERIOD OF TIME. THE LOG CONTAINS NO EVIDENCE OF ANY PROGRAMMING ERROR FOR THIS INFUSION. THE DEVICE WAS TESTED FOR RATE ACCURACY; MEAN FLOW RATE WAS WELL WITHIN SPEC. AFTER PERFORMING RATE ACCURACY TESTING, THE DISPOSABLE SET WAS MANIPULATED BY TWISTING THE PUMPING SEGMENT A FULL TURN THEN PLACING THE SET INTO THE MODULE AND CLOSING THE DOOR. THE DRIP CHAMBER WAS THEN MONITORED FOR FLOW. NONE WAS OBSERVED. WHEN THE DEVICE WAS OPENED FOR INSPECTION THE INTERIOR WAS FOUND TO BE CLEAN AND IN GOOD WORKING CONDITION. THE MECHANISM ASSEMBLY WAS FOUND TO BE CLEAN, INTACT WITH ALL OCCLUDER SPRINGS INSTALLED PROPERLY, AND IN GOOD WORKING CONDITION. IT WAS NOTED THAT THE DEVICE HAD THE LATEST PLATEN AND BEZEL ENHANCEMENTS. ADDITIONALLY, DURING THE INSPECTION AND TESTING OF THE DEVICE, NO ABNORMALITIES WERE OBSERVED THAT COULD LEAD TO AN UNCONTROLLED FLOW EVENT. THE REPORTED OVERINFUSION (UPREGULATED FLOW) COULD NOT BE CONFIRMED NOR REPLICATED DURING TESTING. PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED.

    Description of Event or Problem · 1

    REPORTED EVENT WHERE PUMP WAS TURNED OFF AND ROLLER CLAMP WAS STILL OPEN, NURSE NOTED THAT FLUID CONTINUED TO RUN. UNK PERIOD OF TIME BETWEEN DEVICE BEING TURNED OFF AND UNREGULATED FLOW NOTED. INFUSION WAS DOUBLE-STRENGTH LEVOPHED; PT HAD BEEN WEANED OFF DRIP, SO PUMP HAD BEEN TURNED OFF AND DOOR WAS CLOSED, INFUSION WAS LEFT CONNECTED AS STANDBY INCASE IT NEEDED TO BE RESTARTED. NURSE NOTED PT'S BLOOD PRESSURE WAS RISING DESPITE DRIP BEING TURNED OFF; SHE CHECKED THE INFUSION AND SAW IT DRIPPING AT A MODERATE RATE. SHE CONFIRMED THAT THE INFUSION WAS OFF, SO SHE DISCONNECTED IT FROM THE PT AT THAT POINT. INFUSION WAS SET UP AS A PRIMARY WITH NOTHING PLUGGED INTO ANY PORTS. THERE WAS NO FLUID LEAK FROM THE TUBING, HOWEVER, NURSE REPORTED THAT WHEN THEY DID OPEN THE DOOR THE NOTED THERE WAS A "BEND" IN THE TUBING HIGH IN THE PUMPING SEGMENT, POSSIBLY LIKE A KINK, THAT RESOLVED WHEN THEY REMOVED THE SET FROM THE DEVICE. THE DEVICE WAS REC'D IN GOOD WORKING CONDITION. THE INSTRUMENT SEAL WAS INTACT. A USED DISPOSABLE WAS REC'D ATTACHED TO A 250 ML BAG OF NOREPINEPHRINE IN 5% DEXTROSE, INSTALLED IN THE DEVICE WITH THE DOOR CLOSED. MFR'S REPORT DATE: 4/23/08. INSPECTION OF THE PUMPING SEGMENT FOUND IT TO BE WELDED WHERE THE LOWER OCCLUDER FINGER LINES UP. IT IS NOT KNOWN HOW LONG THE SET HAD BEEN INSIDE THE DEVICE WITH THE DOOR CLOSED. NO OTHER ABNORMALITY OR DAMAGE WAS OBSERVED ON THE SET.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ALARIS SYSTEM PC UNIT