BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIFLO III M/RZ

    MDR report key: 4977 · Received June 17, 1993

    Report

    Report Number
    4977
    Event Type
    Malfunction
    Date Received
    June 17, 1993
    Date of Event
    April 30, 1993
    Report Date
    June 3, 1993
    Manufacturer
    ROSS LABS
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT ON TUBE FEEDING VIA N/G JEVITY 25CC/HR 700CC STARTED AT 10:30 AM AT 25CC/HR AT 1530 NOTED FEEDING PUMP WAS ALARMING, ALL 700CC HAD BEEN ADMINISTERED, DOCTOR MADE AWARE, PUMP TAKEN OFF AND SENT TO BIOMEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-93. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO III M/RZ FEEDING PUMP FPD ROSS LABS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other