BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q

    MDR report key: 2758708 · Received August 24, 2012

    Report

    Report Number
    2758708
    Event Type
    Malfunction
    Date Received
    August 24, 2012
    Date of Event
    December 30, 2011
    Report Date
    August 24, 2012
    Manufacturer
    I-FLOW
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED FOR 13 SEPARATE INCIDENTS OF THE I-FLOW ON-Q PAIN PUMPS NOT WORKING CORRECTLY. THESE ALL OCCURRED BEFORE PATIENT CONTACT WITH THE PUMP, SO NO PATIENT HARM OCCURRED. ALL PUMPS WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. INCIDENTS AND DATES ARE LISTED BELOW:1 - WHEN FILLING AN ORDER FOR AN ON-Q PUMP, FOUND THAT ONE OF THE PUMPS (500ML) HAD LEAKED OUT MUCH OF ITS CONTENTS INTO THE BAG. THE PUMP WAS LOCKED AND SET AT 0, THEREFORE THE PUMP IS PROBABLY DEFECTIVE LOT#152679. 2 - WHEN FILLING AN ORDER FOR AN ON-Q PUMP, FOUND THAT ONE OF THE PUMPS (700ML) HAD LEAKED OUT ALMOST ALL OF ITS CONTENTS INTO THE BAG. PUMP WAS LOCKED AND SET AT 0, THEREFORE IS PROBABLY A DEFECTIVE PUMP (LOT#142641). 3 - WHEN FILLING AN ORDER FOR AN ON-Q PUMP, FOUND THAT ONE OF THE PUMPS (500ML) HAD LEAKED OUT MUCH OF ITS CONTENTS INTO THE BAG. THE PUMP IS PROBABLY DEFECTIVE (LOT#192370). 4 - WHEN FILLING AN ORDER FOR AN ON-Q PUMP, FOUND THAT ONE OF THE PUMPS (700ML) WOULD NOT PUMP. PUMP IS DEFECTIVE (LOT#1628660). 5 - WHEN FILLING AN ORDER FOR AN ON Q PUMP, FOUND THAT ONE OF THE PUMPS (700ML) HAD LEAKED OUT MUCH OF ITS CONTENTS INTO THE BAG. THE PUMP WAS LOCKED AND SET AT 0, THEREFORE THE PUMP IS PROBABLY DEFECTIVE (LOT#142641). 6 - WHEN FILLING AN ORDER FOR AN ON-Q PUMP, FOUND THAT ONE OF THE PUMPS (700ML) HAD LEAKED OUT MUCH OF ITS CONTENTS INTO THE BAG. THE PUMP WAS LOCKED AND SET AT 0, THEREFORE THE PUMP IS PROBABLY DEFECTIVE (LOT# 142641). 7 - WHEN FILLING AN ORDER FOR AN ON-Q PUMP, FOUND THAT ONE OF THE PUMPS (500ML) HAD LEAKED OUT MUCH OF ITS CONTENTS INTO THE BAG. THE PUMP WAS LOCKED AND SET AT 0, THEREFORE THE PUMP IS PROBABLY DEFECTIVE (LOT#172020). 8 - WHEN FILLING AN ORDER FOR AN ON-Q PUMP, FOUND THAT THE PUMP (700ML) HAD BEEN LEAKING ITS CONTENTS INTO THE BAG. THE PUMP WAS LOCKED AND SET AT 0, THEREFORE THE PUMP IS PROBABLY DEFECTIVE (LOT#142641). 9 - WHEN FILLING AN ORDER FOR AN ON-Q PUMP, FOUND THAT THE PUMP (300 ML) WAS DAMAGED. PUMP IS PROBABLY DEFECTIVE (LOT122339). 10 - WHEN FILLING AN ORDER FOR AN ON Q PUMP, FOUND THAT THE PUMP (700ML) IS DEFECTIVE. REF #700ML, LOT# 142641, DATE = 12/16/2011. 11 - WHEN FILLING AN ORDER FOR AN ON Q PUMP, FOUND THAT THE PUMP (700ML) IS NOT WORKING PROPERLY. PUMP IS PROBABLY DEFECTIVE. REF# 700ML, LOT# 142641, DATE = 12/19/2011.12 - WHEN FILLING AN ORDER FOR AN ON Q PUMP, FOUND THAT THE PUMP (700ML) HAD BEEN LEAKING ITS CONTENTS INTO THE BAG. THE PUMP WAS LOCKED AND SET AT 0, THEREFORE THE PUMP IS PROBABLY DEFECTIVE (LOT#142641). 13 - WHEN FILLING AN ORDER FOR AN ON-Q PUMP, FOUND THAT THE PUMP (700ML) HAD BEEN FOUND EMPTY DUE TO THE FACT THAT THE PUMP WAS LEAKING AND IS PROBABLY DEFECTIVE (LOT#142549).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PUMP, INFUSION FRN I-FLOW * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *
    10
    11 *
    12 *
    13
    2
    3
    4
    5
    6
    7
    8
    9