BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAINBUSTER SOAKER

    MDR report key: 2043327 · Received February 25, 2011

    Report

    Report Number
    2026095-2011-00055
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    June 4, 2008
    Report Date
    November 14, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO SAMPLE WAS AVAILABLE FOR EVALUATION AND INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE LOT AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE LOT HISTORY FOUND NO OTHER COMPLAINTS. RESULTS: THE INITIAL REPORTER STATED THAT THE PUMP FINISHED IN 24 HOURS. THE PART AND LOT NUMBER WERE OBTAINED FROM THE PATIENT'S MEDICAL RECORDS. THE RECORD CONTAINED NO INFORMATION OF ANY PROBLEMS WITH THE PUMP. NO PATIENT COMPROMISE OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    (DRUG/DILUENT: MARCAINE 0.5%) (PROCEDURE: SHOULDER NERVE BLOCK ANESTHESIA). PATIENT RECEIVED NO PAIN RELIEF, AND AFTER 24 HOURS THE PUMP WAS COMPLETELY EMPTY. PATIENT HAD SHOULDER SURGERY WITH NERVE BLOCK ANESTHESIC ON (B)(6) 2008. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2008. PER DFU: NOMINAL FILL IS 270ML AND NOMINAL FLOW RATE: 5ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SOAKER ELASTOMERIC PUMP MEB I-FLOW CORP. PM014 812206

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK