BEUDAMED
    FDA Adverse Event Death Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 1999217 · Received February 16, 2011

    Report

    Report Number
    2026095-2011-00031
    Event Type
    Death
    Date Received
    February 16, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    I-FLOW CORP
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO SAMPLE REC'D FOR EVAL AND INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND LOT HISTORY CANNOT BE REVIEWED. RESULTS: W/O THE ACTUAL PRODUCT OR A LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. NO ADD'L INFO HAS BEEN PROVIDED, ALTHOUGH REQUESTED. W/O ADD'L INFO ON THE PUMP, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ADD'L INFO PERTINENT TO THIS COMPLAINT OR THE SAMPLE IS REC'D, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    PT EXPIRED WHILE USING THE ON-Q. THE PUMP HAS NOT BEEN SPECIFICALLY IMPLICATED AT THIS TIME. PUMP WAS PLACED ON (B)(6) 2011 FOLLOWING MASTECTOMY SURGERY. MORNING OF (B)(6) 2011 PT WAS INSTRUCTED ON CARE OF PUMP AND WAS TO BE RELEASED. AROUND 5PM (B)(6) 2011, SURGEON CONTACTED SALES REP ASKING QUESTIONS AND INFORMED SALES REP THAT PT HAD BRADYCARDIA AND HAD BEEN RESUSCITATED AND PLACED ON A VENTILATOR. PUMP WAS REMOVED DURING RESUSCITATION EFFORTS AND LOCATION OF PUMP IS UNK. ON (B)(6) 2011, THE SALES REP WAS INFORMED THAT THE PT HAD BEEN REMOVED FROM MECHANICAL VENTILATION AND HAD EXPIRED APPROX (B)(6), 2011. DATE OF EVENT: (B)(6), 2011. ANP: ASK BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER ELASTOMERIC PUMP MEB I-FLOW CORP P400X4D ANP

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death