BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART SITE INFUSION SET, ALARIS SE PUMP, SIGNATURE EDITION

    MDR report key: 689820 · Received February 23, 2006

    Report

    Report Number
    MW1038124
    Event Type
    Injury
    Date Received
    February 23, 2006
    Date of Event
    February 17, 2006
    Report Date
    February 23, 2006
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report

    Narratives

    Description of Event or Problem · 0

    LABOR AND DELIVERY HAVING TROUBLE WITH NEW ALARIS TUBING ALARMING "OCCLUSION UPSTREAM". TUBING RUNNING OXYTOCIN AT 12MU AND CONTRACTION PATTERN EVERY 3 MINUTES. PUMP WOULD ALARM, THEN WHEN RESET WOULD RUN FOR 10-15 MINUTES, THEN ALARM AGAIN. TUBING WAS SWITCHED OUT AND THE PUMP CONTINUED TO ALARM EVERY 15-30 MINUTES. WHEN TUBING WAS SWITCHED TO ANOTHER LOT#, FHR HAD DECEL TO 90'S FOR 5 MINS AND TERBUTALINE TO 0.25 MG SQ HAD TO BE GIVEN TO STOP CONTRACTIONS. PITOCIN WAS IMMEDIATELY TURNED OFF. PT UTERUS WAS HYPERSTIMMING AT THE TIME, WITH NO RESTING TONUS. AFTER TERBUTALINE WAS GIVEN AND PITOCIN WAS SHUT OFF, FHR RETURNED TO BASELINE OF 140'S AND HAD REACTIVITY. INVESTIGATION BY CARDINAL HEALTH ALARIS PRODUCTS, FOLLOWING PRODUCT COMPLAINT FOUND THAT DURING MFR, 1 OF 5 MOLDS WAS FAULTY PRODUCING A BAD ACCUSLIDE THAT DID NOT SEAT PROPERLY AND SUBSEQUENTLY DOES NOT OPEN RESULTING IN UPSTREAM OCCLUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 SMART SITE INFUSION SET, ALARIS SE PUMP, SIGNATURE EDITION SMARTSITE INFUSION SET FPA CARDINAL HEALTH ALARIS PRODUCTS SMARTSITE INFUSION 06015638 AND BELOW

    Patients

    Seq Age Sex Outcome Treatment
    0 30 YR Disability