BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSS PATROL

    MDR report key: 751530 · Received August 17, 2005

    Report

    Report Number
    MW1036388
    Event Type
    Injury
    Date Received
    August 17, 2005
    Date of Event
    August 14, 2005
    Report Date
    August 17, 2005
    Manufacturer
    ROSS LABORATORIES
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    DIETICIAN

    Narratives

    Description of Event or Problem · 1

    FATHER PRIMARY CAREGIVER REPORTED TO US 08/16/2005 THAT PT WAS HOOKED UP TO ROSS PATROL PUMP BOTH NIGHTS AT 9PM. THE PUMP KEPT ALARMING "FREEFLO" AND "NOFLOW" THROUGHOUT BOTH NIGHTS. HE CHECKED THE PUMP AND TUBING, TURNED IT OFF AND BACK ON EACH TIME IT ALARMED. HE REPORTS THAT THE FORMULA (120ML TOTAL -10 ML/HR X 12 HRS) RAN OUT AT 8AM ON 08/15/2005 AND 7AM ON 08/16/2005- INSTEAD OF 9 AM. FATHER REPORTS NO ADVERSE EFFECTS, NO N/V/D, ABDOMINAL DISTENTION, CRAMPING. ETC. PT ALSO RECEIVING HOME TPN USING SABRATEK 6060. NO PROBLEMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROSS PATROL ENTERAL FEEDING PUMP LZH ROSS LABORATORIES FLEXIFLO PATROL-52036 *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Other| R 2) SABRATEK 6060| 1) HOME TPN