BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOEY 1000ML PUMP SET

    MDR report key: 6186067 · Received December 19, 2016

    Report

    Report Number
    1282497-2016-01064
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 22, 2016
    Report Date
    August 9, 2018
    Manufacturer
    COVIDIEN
    Product Code
    LZH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 12/19/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    SAMPLES WERE NOT RECEIVED FOR THE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT RECEIVED WITH THE COMPLAINT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE DEFECT AND ROOT CAUSE ANALYSIS. A CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT AN ADVERSE EVENT OCCURRED WITH A FEEDING PUMP SET. THE CUSTOMER REPORTED THAT DURING THE MIDNIGHT ASSESSMENT, RN AND CA NOTICED FEED WAS LEAKING FROM THE ENTERAL FEED BAG ONTO THE BED. THE LEAK WAS WHERE THE CLEAR PLASTIC TUBING MEETS THE PURPLE PLASTIC, BY THE PURPLE WINGS. THE PATIENT WAS A TYPE 1 DIABETIC. IT HAD BEEN ABOUT 60-70 MINUTES SINCE THIS RN HAD ASSESSED THE INFUSION. THE PATIENT'S BLOOD GLUCOSE WAS CHECKED AND IT WAS 33. THE PATIENT WAS AWAKE, ALERT, AND INTERACTIVE (SMILING AND ON PHONE). THE PHYSICIAN WAS NOTIFIED AND CAME TO THE BEDSIDE, JUICE WAS GIVEN TO THE PATIENT VIA GT. A NEW FEED BAG WAS PLACED AND CONTINUOUS OVERNIGHT FEEDS RESUMED. BLOOD GLUCOSE WAS RECHECKED AFTER 15MINS AND IT WAS 40. PATIENT WAS STILL ALERT, AWAKE AND INTERACTIVE. PROVIDER AT BEDSIDE AND NOTIFIED AND D10 BOLUS WAS GIVEN. BLOOD GLUCOSE WENT TO 188 AFTER BOLUS WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836068 JOEY 1000ML PUMP SET FEEDING PUMP SET LZH COVIDIEN 763656

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R