BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LC 5000 W/DATAPORT

    MDR report key: 1772052 · Received July 14, 2010

    Report

    Report Number
    2921482-2010-00510
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 17, 2010
    Report Date
    June 17, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K911401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY VOLUNTARY MEDWATCH RECEIVED THAT STATED: "PUMP WAS SET TO INFUSE AT D10W AT 7ML/HR AT APPROX 2100. PUMP INFUSING WITHOUT DIFFICULTY - NO ALARMS. NOTICED 250ML BAG EMPTY AT 0300. PUMP RECORDED INFUSING 28.7 ML." UPON FURTHER QUERY, THE FOLLOWING INFO WAS PROVIDED THAT INDICATED THAT THE PT RECEIVED MORE MEDICATION THAN INTENDED. THE CUSTOMER CONTACT INDICATED THAT THE 10% DEXTROSE WAS BEING DELIVERED THROUGH AN UMBILICAL CORD CATHETER. THE PUMP PROGRAMMING WAS CHECKED BY 2 NURSES. AT 0300, THE NURSE NOTED, THE 10% DEXTROSE CONTAINER WAS EMPTY. AT THIS TIME, IT WAS NOTED THAT THE NEONATE "WAS MOVING AND CRYING AND HAD MILD EDEMA AND INCREASED URINE OUTPUT". THE PHYSICIAN WAS NOTIFIED AND ORDERED UNSPECIFIED LAB WORK AND A CT (COMPUTED TOMOGRAPHY) SCAN. THE CT SCAN FOUND NO SWELLING OF THE BRAIN. RESULTS OF THE LAB WORK DRAWN WERE NOT PROVIDED. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE PT WAS TREATED WITH "2/3 OF THE MAINTENANCE DOSE TO PREVENT HYPOGLYCEMIA" WITH A REPLACEMENT DEVICE. THE CUSTOMER CONTACT STATED THAT THERE WERE "NO LONG TERM EFFECTS TO THE NEONATE." THE CUSTOMER CONTACT INDICATED THAT A BURETTE TUBING SET WAS NOT USED DURING THIS DELIVERY; BUT THE NICU (NEONATAL INTENSIVE CARE UNIT) WILL BE USING THEM IN THE FUTURE. THOUGH REQUESTED, THE CUSTOMER CONTACT DECLINED TO PROVIDE ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC 5000 W/DATAPORT 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Required Intervention D10W, MFG BY HOSPIRA, INC.