BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2842854 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05774
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 28, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE IS NOT AVAILABLE. THIS REPORT WAS NOT CONFIRMED AND NO ASSIGNABLE CAUSE COULD BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE, IN (B)(6), OF A BACTERIAL INFECTION OF PERITONITIS COINCIDENT WITH PHYSIONEAL 40 1.36% AND 2.27% AND EXTRANEAL THERAPIES. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN, CLOUDY EFFLUENT, FEVER AND VOMITING. REMEDIAL TREATMENT WAS INITIATED, WHICH INCLUDED VANCOMYCIN (500 MG, 1X/DAY, IP), CEFTAZIDIME (1 G, 1X/DAY, IP), FLUCLOXACILIN (500 MG, 3X/DAY, ORAL), CIPROFLOXACIN (1 G, 1X/DAY, IP) AND ALTEPLASE (5 MG, EVERY 5 DAYS, ROUTE NOT REPORTED). THE PATIENT WAS HOSPITALIZED FOR THIS EVENT. THE PERITONITIS WAS CAUSED BY AN INFECTION OF THE EXIT SITE AND SUBCUTANEOUS TUNNEL. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS REPORTEDLY RECOVERING. ADMINISTRATION OF VANCOMYCIN ENDED ON (B)(6) 2012. ADMINISTRATION OF FLUCLOXACILIN ENDED ON (B)(6) 2012, HOWEVER THE EFFLUENT REMAINED CLOUDY. THEREFORE THERAPY WITH CEFTAZIDIME (1 G/DAY, IP) AND CIPROFLOXACIN (1 G/DAY, IP) WAS TO BE CONTINUED FOR ANOTHER 14 DAYS. ON (B)(6) 2012, THE NURSE VISITED THE PATIENT TO COLLECT ADDITIONAL INFORMATION AND TO PERFORM RE-TRAINING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R B COMPLEX| IRON| HYDROXYZINE| FUROSEMIDE| FOLIC ACID| CALCIUM CARBONATE| PHYSIONEAL| SALMETEROL/FLUTICASONE PROPIONATE.| DARBEPOETIN| ESCITALOPRAM| OMEPRAZOLE| PARICALCITOL| EXTRANEAL| LORAZEPAM