BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON Q PAIN RELIEF SYSTEM

    MDR report key: 8671257 · Received June 4, 2019

    Report

    Report Number
    MW5087122
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 29, 2019
    Report Date
    May 31, 2019
    Manufacturer
    HALYARD / AVANOS MEDICAL (LAB) - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    POD #1, BY REGIONAL RESIDENT FOR F/U OF ON Q. AT THAT TIME THE MOM REPORTED THE PT HAD DONE WELL OVERNIGHT AFTER SURGERY BUT HAD STARTED HAVING A LOT OF PAIN YESTERDAY DURING THE DAY. SHE ALSO NOTED THE ON Q BALL WAS ALREADY EMPTY. I REACHED THE ROOM LAST NIGHT VIA TEXT MESSAGE AND SHE CONFIRMED THE ON Q BALL HAD BEEN EMPTY SINCE 0600, APPROX 17 HOURS AFTER THE BALL WAS CONNECTED TO THE FEMORAL PNC. SHE SENT ME A PICTURE SHOWING WHAT APPEARS TO BE A COMPLETELY EMPTY ON Q BALL, (400 ML WAS IN ORIGINAL PAIN BALL). THEREFORE THE BALL EMPTIED >33 HOURS EARLIER THAN WOULD BE EXPECTED WITH A RATE OF 8CC/HR. MOST LIKELY PUMP EITHER MALFUNCTIONED OR HAD A LEAK IN IT. MOM DID NOT NOTICE ANY WITNESS OR LEAKAGE AROUND THE BALL OR CATHETER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462006 ON Q PAIN RELIEF SYSTEM PUMP, INFUSION, ELASTOMERIC MEB HALYARD / AVANOS MEDICAL (LAB) - IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR