BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12 FOOT EXTENSION SET EASYLOCK CONNECTOR

    MDR report key: 1820517 · Received August 31, 2010

    Report

    Report Number
    1423500-2010-03011
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED, THEREFORE NO EVALUATION WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ABSTRACT TITLED "THE EFFECTS OF THE SURGICAL TECHNIQUE FOR KYPHOPLASTY", THAT: FROM (B)(6) 2002 TO (B)(6) 2009, PERCUTANEOUS BILATERAL TRANSPEDICULAR KYPHOPLASTY WITH SINGLE BALLOON WAS PERFORMED IN 86 PATIENTS WITH ONLY PAINFUL OSTEOPOROTIC VERTEBRAL FRACTURES. ALL PATIENTS EXPERIENCED DRAMATIC PAIN RELIEF OR DISAPPEARANCE AFTER THE PROCEDURES. THE RATE OF CEMENT LEAKAGE WAS 3.2% AND 29.1% IN VEINS AND SOFT TISSUES, AROUND BODY, INTERVERTEBRAL. NO FURTHER INFORMATION WAS REPORTED. IT IS UNKNOWN IF THE BONE CEMENT USED WAS HV-R. NOTE: MEDTRONIC SPINE, LLC DOES NOT CURRENTLY DISTRIBUTE PRODUCT IN CHINA

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL REPORT BY A NURSE FROM THE USA OF PERITONITIS AND "HEART GAVE UP" (CODED AS CARDIAC ARREST) IN A (B)(6) FEMALE COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING INFORMATION. ON (B)(6) 2010, THE PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR A MASSIVE INFECTION. ON (B)(6) 2010, THE PATIENT DIED OF CARDIAC ARREST. THE NURSE REPORTED THE PATIENT'S INFECTION WAS PERITONITIS. IT WAS UNREPORTED WHETHER AN AUTOPSY WAS PERFORMED. DIANEAL THERAPY WAS ONGOING UNTIL THE DATE OF DEATH. IT WAS UNKNOWN WHETHER THE PATIENT RECOVERED FROM THE PERITONITIS. THE NURSE REPORTED THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. A CAUSALITY STATEMENT WAS NOT PROVIDED FOR THE CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12 FOOT EXTENSION SET EASYLOCK CONNECTOR SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R DIANEAL PD4 AMBUFLEX 1.5%, 2..5% AND 4.25%