BEUDAMED
    FDA Adverse Event Death Summary report: N

    IV TUBING

    MDR report key: 1307 · Received September 4, 1992

    Report

    Report Number
    1307
    Event Type
    Death
    Date Received
    September 4, 1992
    Date of Event
    May 13, 1992
    Report Date
    August 27, 1992
    Manufacturer
    MCGAW OF PUERTO RICO, INC.
    Product Code
    FPK
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    AT 0005 ON 5/14/92 IT WAS DISCOVERED THAT AN IV BOTTLE OF 1000CC HUNG AT 2100 ON 5/13/92 WAS EMPTY. AN IV OF 1000CC WAS HUNG AT 2100 BY AN EVENING NURSE AND CHECKED AT 2200 AT WHICH TIME THE IV HAD 875CC LEFT. THE IV WAS CHECKED AT 2230 AND RUNNING AS ORDERED. AT 0005 THE IV WAS FOUND TO BE EMPTY AND THE CLAMP ON THE TUBING WAS 3/4/ CL;OSED. THE PATIENT RECEIVED A BOLUS OF FLUID BETWEEN 2230 AND 0005. THE IV TUBING DELIVERED THE FLUID TO THE PATIENT WITH THE ROLLER CLAMP REGULATING FLOW RATE. THE FLUID WENT INTO THE PATIENT MORE RAPIDLY THAN HAD BEEN ANTICIPATED FOLLOWING ADJUSTMENT OF THE ROLLER CLAMPDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IV TUBING N/A FPK MCGAW OF PUERTO RICO, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death