BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIFLO COMPANION PUMP

    MDR report key: 88897 · Received May 2, 1997

    Report

    Report Number
    1526605-1997-00001
    Event Type
    Injury
    Date Received
    May 2, 1997
    Date of Event
    March 30, 1997
    Report Date
    May 2, 1997
    Manufacturer
    FRANTZ MEDICAL DEVELOPMENT, LTD.
    Product Code
    LZH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT SUFFERED POST-OPERATIVE HEMORRHAGE AND RENAL FAILURE AND PLACED IN ICU FOR APPROXIMATELY 3 WEEKS FOLLOWING CARDIAC SURGERY, DOUBLE VALVE REPLACEMENT, AND HAD RECEIVED OSMOLITE BY N/G TUBE FOR 18 DAYS. DUE TO WORSENING RENAL FAILURE HE WAS CHANGED TO NEPRO AT 2100 ON 3/29/97. THE PT WAS NOT CHECKED UNTIL 0100 ON 3/30/97, FEED WAS NOT BEING DELIVERED. THE FEED HAD CURDLED OR GONE LUMPY AND WAS BLOCKING THE PROXIMAL END OF THE FEEDING SET. PT WAS INSULIN DEPENDENT DIABETIC. MEDICAL REPORT INDICATED THE PT EXPERIENCED SEVERE HYPOGLYCEMIA. CEREBRAL DAMAGE ASSESSED BY HEALTH CARE PROFESSIONAL BASED ON COMATOSED CONDITION SINCE THE EVENT. PT EXPIRED ON 4/3/97. CAUSE OF DEATH LISTED AS RENAL FAILURE AND PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO COMPANION PUMP 80LZH - ENTERAL FEEDING PUMP LZH FRANTZ MEDICAL DEVELOPMENT, LTD. N/AP N/AP

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Disability CONTINUOUS FRUSEMIDE VIA IV LINE (DATES NOT| PROVIDED).| ACTRAPID (HUMAN MONOCOMPONENT INSULIN) 2U/HR