BEUDAMED
    FDA Adverse Event Other Summary report: N

    KANGAROO JOEY, PUMP W/POLE CLMP

    MDR report key: 3445217 · Received October 23, 2013

    Report

    Report Number
    3006451981-2013-00358
    Event Type
    Other
    Date Received
    October 23, 2013
    Date of Event
    September 24, 2012
    Report Date
    September 26, 2013
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC
    Product Code
    LZH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2013. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2013 THAT A PATIENT HAD AN ISSUE WITH A KANGAROO JOEY PUMP. THE CUSTOMER REPORTED THAT A CHILD WAS RECEIVING GASTROSTOMY FEEDS WITH A KANGAROO JOEY PUMP DURING THE NIGHT. THE MOTHER FED HIM AGAINST THE ADVICE OF THE VISITING NURSE UNTIL 2:30 AM IN THE MORNING. THE MOTHER WOKE SUDDENLY TO FIND THAT THE TUBING FROM HIS FEEDING SET WAS WRAPPED AROUND HIS NECK TWICE. THE MOTHER REPORTS THERE WAS NO RESPIRATORY DIFFICULTIES OR CHOKING. THE VISITING NURSE REPORTED NO MARKS ON HIS NECK WHEN VISITING HIM THE FOLLOWING MORNING. THE PT IS STATED TO BE FINE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543283 KANGAROO JOEY, PUMP W/POLE CLMP JOEY LZH COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC 383400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening