BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPAT

    MDR report key: 2394960 · Received December 27, 2011

    Report

    Report Number
    2110851-2011-00003
    Event Type
    Injury
    Date Received
    December 27, 2011
    Date of Event
    October 26, 2011
    Report Date
    December 17, 2011
    Manufacturer
    NESTLE HEALTHCARE NUTRITION, INC.
    Product Code
    LZH
    PMA / PMN Number
    K891575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED ON (B)(6) 2011, HOWEVER, COMPANY WAS NOT NOTIFIED UNTIL (B)(6) 2011 DURING A ROUTINE VISIT TO FACILITY. FROM THE EVALUATION CODE HIERARCHY, THE FOLLOWING CODE (61) IS SUSPECTED, HOWEVER, THIS CANNOT BE CONFIRMED AS THE INFO FROM THE NURSE AND THE DIRECTOR OF NURSING ARE IN CONFLICT. THE DIRECTOR OF NURSING DOES NOT BELIEVE THE PUMP WAS CORRECTLY SET UP IN THIS CASE.

    Description of Event or Problem · 1

    PT ON TUBE FEEDING STARTED AT APPROX 3:30 PM WAS FOUND TO HAVE APPARENTLY BEEN OVERFED AT 7:30 PM. THERE WAS A TUBE FEEDING ADMINISTRATION SET ATTACHED TO THE PTS G-TUBE BUT IT WAS NOT ATTACHED TO THE PUMP NOR WAS THE PUMP ON. THE 1500ML BAG WAS EMPTY. THE PT WAS CLEARLY IN RESPIRATORY DISTRESS WITH AUDIBLE RALES AND RONCHI WITH TUBE FEEDING FORMULA ON THE BED. THE NURSE CARING FOR THE PT REPORTS TO HAVE HUNG A 1500ML BAG OF FORMULA AT 3:30 OR 4:00PM. THE DIRECTOR OF NURSING SENT THE PT TO THE HOSPITAL IMMEDIATELY THAT EVENING ON (B)(6) 2011 WHERE THE PT WAS DIAGNOSED WITH ASPIRATION PNEUMONIA AND ARF - ACUTE RESPIRATORY FAILURE. THE PT WAS PUT ON ANTIBIOTICS WHILE IN HOSPITAL, HOWEVER, THERE IS NO RECORD OF HER BEING VENTED. THE PT STAYED IN THE HOSPITAL UNTIL (B)(6) 2011, WHEN SHE RETURNED BACK TO THE FACILITY IN A STABLE CONDITION. THE DIRECTOR OF NURSING DOES NOT BELIEVE THE ADMINISTRATION SET WAS EVER CONNECTED TO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAT ENTERAL FEEDING PUMP LZH NESTLE HEALTHCARE NUTRITION, INC. 199235

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization