BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 2003484 · Received March 1, 2011

    Report

    Report Number
    1423500-2011-02576
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED THEREFORE NO EVALUATION WAS PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED OR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIRST INCIDENCE OF PERITONITIS IS BEING ADDRESSED IN THIS REPORT. THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE INCIDENT WAS UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. FOLLOW UP INFORMATION WILL BE SUBMITTED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT FROM A HOME PATIENT (HP) ON (B)(6) 2011 THAT IN (B)(6) 2010, SHE SWITCHED TO THE NEW 3 PRONG CASSETTE. ABOUT 1 WEEK LATER ON (B)(6) 2010, THE PATIENT EXPERIENCED ABDOMINAL CRAMPING COINCIDENT WITH LOCAL PD4 AMBUFLEX (DOSE UNKNOWN). ON THE (B)(6) 2010, THE PATIENT EXPERIENCED STOMACH PAIN AND CLOUDY EFFLUENT. THAT SAME DAY THE PATIENT WAS HOSPITALIZED AND A PERITONEAL DIALYSIS (PD) EFFLUENT CULTURE WAS PERFORMED. THE PATIENT HAD PERITONITIS. THERE WAS NO BREAK IN ASEPTIC TECHNIQUE AND NO LEAKING FROM THE CASSETTE. TREATMENT FOR THE EVENT OF PERITONITIS INCLUDED A DOSE OF INTRAVENOUS VANCOMYCIN AND IP VANCOMYCIN EVERY 3 DAYS FOR THREE WEEKS. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THERE WAS NO EXIT SITE OR TUNNEL INFECTION. IN (B)(6) 2011, 2 WEEKS AFTER ANTIBIOTIC THERAPY, THE PATIENT HAD NO SYMPTOMS OF THE PERITONITIS, CRAMPING, STOMACH PAIN, OR CLOUDY EFFLUENT. THE PERITONITIS HAD RESOLVED. THE LAST DOSE OF ANTIBIOTIC THERAPY WAS (B)(6) 2011. ON (B)(6) 2011, A REPEAT PERITONEAL EFFLUENT WAS PERFORMED WHICH REVEALED NO GROWTH. ON (B)(6) 2011, THE PATIENT DRAINED HER PD SOLUTIONS. THAT SAME DAY THE PATIENT EXPERIENCED ABDOMINAL CRAMPING. ON (B)(6) 2011 THE PATIENT REPORTED THAT SHE WAS SCHEDULED FOR A KIDNEY AND PANCREAS TRANSPLANT. A PD EFFLUENT CULTURE WAS PERFORMED THAT SAME DAY WITH TEST RESULTS PENDING. THE PATIENT WAS SUSPICIOUS SHE HAD PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT STATED HER KIDNEY AND PANCREATIC TRANSPLANT WAS ON HOLD. THE REPORTER THOUGHT IT WAS POSSIBLE THE EVENT OF PERITONITIS WAS RELATED TO THE 3 PRONG CASSETTE. ON (B)(6) 2011, FOLLOW-UP INFORMATION WAS OBTAINED FROM THE PD NURSE. NURSE DID NOT KNOW IF THE PATIENT HAD A RECURRENT PERITONITIS VERSUS A BREAK THROUGH PERITONITIS. THE NURSE THOUGHT THE EVENT OF PERITONITIS COULD HAVE BEEN RELATED TO TECHNIQUE SINCE THE PATIENT HAD SWITCHED FROM THE "SPIKE TO LURE". THE NURSE CONFIRMED THE PATIENT HAD NO PRIOR INFECTIONS PREVIOUSLY TO THE (B)(6) 2010 DIAGNOSIS. THE NURSE CONFIRMED THE PATIENT HAD BEEN TRAINED ON THE 3 PRONG CASSETTE PRIOR TO USE. AT THE TIME OF THIS REPORT THE EVENT OF PERITONITIS WAS ONGOING. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R HOME CHOICE CYCLER| LOCAL PD4 ULTRABAG,| LOCAL PD4 AMBUFLEX,