BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 3042226 · Received April 4, 2013

    Report

    Report Number
    2026095-2013-00055
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    January 1, 2006
    Report Date
    January 31, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVALUATION AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RESULTS: THE INFORMATION CONTAINED IS FROM INFORMATION RECEIVED FROM THE DIRECTOR OF SURGERY. THE COMPLAINT WAS OPENED SO THAT A MEDICAL DEVICE REPORT (MDR) CAN BE FILED WITH THE US FOOD AND DRUG ADMINISTRATION. NO FURTHER INVESTIGATION WILL BE CONDUCTED. CONCLUSION: I-FLOW'S LEGAL DEPARTMENT HAS MADE CONTACT WITH THE DIRECTOR OF SURGERY, NO FURTHER INFORMATION WILL BE OBTAINED. AS OF 11/9/2006 I-FLOW UPDATED THE ON-Q PUMP DIRECTIONS FOR USE (DFU), TO INCLUDE THE FOLLOWING IN THE WARNINGS SECTION: "AVOID PLACING THE CATHETER IN JOINT SPACES. ALTHOUGH THERE IS NO DEFINITIVE ESTABLISHED CAUSAL RELATIONSHIP, SOME LITERATURE HAS SHOWN A POSSIBLE ASSOCIATION BETWEEN CONTINUOUS INTRA-ARTICULAR INFUSIONS (PARTICULARLY WITH BUPIVACAINE) AND THE SUBSEQUENT DEVELOPMENT OF CHONDROLYSIS." (DFU 1307011). ON 8/8/2007, I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN ENTITLED "WHAT WE KNOW ABOUT CHONDROLYSIS TODAY". (1303722, REV. E), IN ANY EVENT, THE ON-Q PUMP WAS NOT PLACED INTO INTRA­ ARTICULAR SPACE DURING THE PATIENT'S FIRST, 2006 SURGERY, AND THE PUMP WAS NOT USED AT ALL IN THE PATIENT'S SECOND, 2011 SURGERY.

    Description of Event or Problem · 1

    DRUG/DILUENT: UNKNOWN. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: SHOULDER SURGERY, ROTATOR CUFF REPAIR. CATHPLACE: OUTSIDE THE JOINT. THE DIRECTOR OF SURGERY CONTACTED OUR SALES REP. TO INFORM I-FLOW THAT AN ORTHOPEDIC SURGEON HAD CONTACTED HIM TO REPORT A PATIENT WHO HAD SHOULDER SURGERY IN 2006 IN WHICH AN ON-Q PUMP WAS USED. THE DOCTOR STATED THE CATHETER OF THE FIRST SURGERY WAS NOT INTRA-ARTICULAR. THE PATIENT UNDERWENT A SECOND SURGERY IN 2011 AND THE PATIENT REPORTED TO HAVE ISSUES AFTER THE SECOND SURGERY. ON-Q PUMP WAS NOT USED IN THE SECOND SURGERY. THE PATIENT WENT TO SEEK A SECOND OPINION AND THE SURGEON COMMUNICATED TO THE PATIENT THAT THERE WERE LAW SUITS REGARDING THE ON-Q PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137781 ON-Q PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other