BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q

    MDR report key: 4843562 · Received June 2, 2015

    Report

    Report Number
    4843562
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    February 9, 2015
    Report Date
    April 8, 2015
    Manufacturer
    HALYARD HEALTH, INC
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PT REPORTED TO AT SURGEON'S OFFICE AND COMPLAINED OF ISSUES WITH ON-Q PUMP. POSSIBLY LEAKING, NOT WORKING. FOLLOW UP WITH OFFICE MANAGER: "TOO MANY PATIENTS ARE HAVING VARIOUS PROBLEMS WITH THE ON-Q PUMP. ONCE THEY GET HOME FROM THE HOSPITAL AND THE PUMP IS LEAKING OR THEY SEE STREAKS OF BLOOD IN THE LINE, THEY FREAK OUT. THEY THINK IT ISN'T WORKING, UNTIL IT COMES OUT EARLY AND THEN THEY HAVE A HIGH LEVEL OF PAIN. THEY DON'T NECESSARILY GET ISSUES RESOLVED WITH ON CALL DOCTOR OR EVEN ON-Q 800 NUMBER OR THE ON-Q PEOPLE SAY THAT A NURSE WILL GET BACK TO THEM IN A FEW HOURS! PATIENTS NEED MORE EDUCATION ABOUT WHATEVER PUMP THEY ARE USING SO THAT WHEN THEY GET HOME THEY CAN TROUBLE SHOOT EASIER. I THINK A MANUAL FOR THE PRODUCT WOULD HELP WITH A TROUBLESHOOTING SECTION AND AN 800 NUMBER THAT SOMEONE WILL ANSWER QUESTIONS 24/7 RIGHT AWAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356647 ON-Q PUMP, INFUSION MEB HALYARD HEALTH, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR