BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1891235 · Received November 4, 2010

    Report

    Report Number
    1423500-2010-05256
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBERS; H10G23062, H10F28121, AND H10E23033 WITH NO DEFECTS NOTED. 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. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON AN UNREPORTED DATE, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED AT THAT TIME. THE NURSE DID NOT PROVIDE INFORMATION REGARDING TREATMENT. IT WAS NOT REPORTED WHETHER DIANEAL THERAPY WAS ONGOING AT THE TIME OF THE EVENT. IT WAS NOT REPORTED WHETHER THE PERITONITIS RESOLVED. THE NURSE DECLINED TO PROVIDE FURTHER INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT HAD A CEMENTED SIZE 3 DEFINITION HIP STEM, 54 MM VITALOCK CUP 0 DEGREE LINER WITH 28 MM HEAD IMPLANTED ABOUT 12 YEARS AGO. THERE WAS SIGNIFICANT OSTEOLYSIS AROUND FEMORAL COMPONENT PROXIMALLY AND THE STEM HAD MIGRATED TO A VARUS POSITION. THE STEM WAS EXTRACTED FROM THE CANAL WITH LITTLE TO NO FORCE BEFORE THE ETO. THE STEM HAD NO RESIDUAL BONE CEMENT ATTACHED TO STEM. THERE WAS A COMPLETE DEBONDING BETWEEN STEM AND BONE CEMENT. THE POLY INSERT SHOWED VERY LITTLE WEAR. THE OSTEOLOCK CUP WAS IN GOOD ALIGNMENT AND WELL FIXED, IT DID NOT NEED TO BE REPLACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization