BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA INFUSION

    MDR report key: 1526794 · Received November 12, 2009

    Report

    Report Number
    2031920-2009-00002
    Event Type
    Injury
    Date Received
    November 12, 2009
    Date of Event
    May 30, 2006
    Report Date
    October 2, 2009
    Manufacturer
    ADVANCED INFUSION, INC.
    Product Code
    MEB
    PMA / PMN Number
    K071532
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFICALLY, THE PATIENT ALLEGED THAT THE PRODUCT LABELING WAS INADEQUATE IN THAT IT DID NOT ADEQUATELY WARN THAT THE SAFETY FOR A CONTINUOUSLY INJECTED ANESTHETIC HAD NOT BEEN ESTABLISHED FOR USE IN THE SHOULDER JOINT; THAT CONTINUOUS INFUSION OF ANESTHETICS INTO THE SHOULDER JOINT SPACE MAY CAUSE SERIOUS INJURY TO THE JOINT CARTILAGE; THAT THE LABELING DID NOT SPECIFICALLY PRECAUTION AGAINST PLACING THE CATHETER IN THE JOINT SPACE. A REVIEW OF ADVANCED INFUSION, INC.'S COMPLAINT DATABASE REVEALED NO CORRESPONDING COMPLAINT. ADVANCED INFUSION, INC. CANNOT CONFIRM THE BASIS OF THIS COMPLAINT. SIGNIFICANT TIME HAS PASSED BETWEEN THE EVENT AND THE ALLEGATIONS OF THE COMPLAINT. NO PRODUCT IS AVAILABLE FOR INVESTIGATION. ADVANCED INFUSION, INC. BELIEVES THAT ITS PRODUCTS DO NOT LEAD TO NARROWING OF THE JOINT SPACE AND/OR CHONDROLYSIS WHEN USED ACCORDING TO THE PRODUCT'S LABELING AND DIRECTIONS FOR USE.

    Description of Event or Problem · 1

    ON 09/05/2009 ADVANCED INFUSION, INC. WAS SERVED BY A PATIENT ALLEGING THAT CONTINUOUS INFUSION OF MARCAINE, RESULTED IN PERMANENT DAMAGE TO CARTILAGE OF HER RIGHT SHOULDER JOINT, A/K/A CHONDROLYSIS. IN 2006, AN ADVANCED INFUSION ANESTHETIC DELIVERY SYSTEM, A "PAIN PUMP," USING A CATHETER AFFIXED TO THE PATIENT'S RIGHT SHOULDER, INTO HER SUBACROMIAL SPACE, POST-ARTHROSCOPIC SURGERY FOR BANKART REPAIR & ROTATOR CUFF DÉBRIDEMENT. THE FOLLOWING MONTH, THE PATIENT HAD A SECOND SURGERY ON THE SAME SHOULDER FOR A RECURRENT BANKART LABRAL REPAIR. A 450 CC "PAIN PUMP" WITH 300 CC OF 0.5% MARCAINE AND A CATHETER WERE USED. THE CATHETER WAS INSERTED INTO A SHOULDER JOINT. TWO MONTHS LATER, THE PATIENT HAD A THIRD SURGERY ON THE SAME SHOULDER FOR A DEBRIDEMENT AND LABRAL REPAIR. A 450 CC "PAIN PUMP" WITH 300 CC OF 0.5% MARCAINE AND A CATHETER WERE USED. THE CATHETER WAS INSERTED INTO THE SHOULDER JOINT. IN 2007, THE PATIENT HAD A FOURTH SURGERY ON THE SAME SHOULDER FOR PARTIAL LABRAL TEAR REPAIR WHERE A "PAIN PUMP" WITH THE CATHETER INSERTED INTO THE SUBACROMIAL SPACE. DURING ALL SURGERIES, AN A450 INFUSION PUMP WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA INFUSION PAIN PUMP MEB ADVANCED INFUSION, INC. A450

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR