BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2385129 · Received December 21, 2011

    Report

    Report Number
    1423500-2011-17217
    Event Type
    Death
    Date Received
    December 21, 2011
    Date of Event
    November 1, 2011
    Report Date
    November 28, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE 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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE IS UNDETERMINED. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF FATAL CARDIORESPIRATORY ARREST, SEIZURE AND BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR BACTERIAL GROWTH IN A PATIENT COINCIDENT WITH DIANEAL PD2 UNKNOWN THERAPY. ON (B)(6) 2011, THE PATIENT BEGAN EMERGENCY THERAPY WITH DIANEAL PD2, UNKNOWN, THERAPY (DOSE, LOT NUMBER AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) VIA CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) FOR EDEMATOUS STATUS AND HYPERTENSION. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL THAT SAME DAY WITH THE DIAGNOSIS OF END STAGE RENAL DISEASE (ESRD) SECONDARY TO DIABETIC NEPHROPATHY AND HYPERTENSION. DURING THE FIRST WEEK OF (B)(6) 2011, THE PATIENT EXPERIENCED CLOUDY PERITONEAL EFFLUENT. IN EARLY (B)(6) 2011, THE PATIENT BEGAN REMEDIAL TREATMENT WITH AN UNSPECIFIED ANTIBIOTIC, PROPHYLACTICALLY. ON (B)(6) 2011, THE PATIENT WAS STILL EXPERIENCING CLOUDY PERITONEAL EFFLUENT . ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT BEGAN REMEDIAL TREATMENT WITH AMIKACIN (12MG FOR FIVE DAYS, ROUTE NOT REPORTED). ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT EXPERIENCED A SEIZURE. ON (B)(6) 2011, THE PATIENT EXPERIENCED CARDIO-RESPIRATORY ARREST MANIFESTED AS SHORTNESS OF BREATH. CARDIOPULMONARY RESUSCITATION (CPR) WAS PROVIDED AS AN INTERVENTION, HOWEVER THE PATIENT DIED. THE CAUSE OF DEATH WAS CARDIO-RESPIRATORY ARREST. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. IT WAS UNKNOWN IF THE EVENTS OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR BACTERIAL GROWTH AND SEIZURE HAD RESOLVED PRIOR TO THE PATIENT'S DEATH. DIANEAL PD2 THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE STATED THE EVENT OF CARDIO-RESPIRATORY ARREST WAS UNRELATED TO DIANEAL PD THERAPY. A CAUSALITY STATEMENT WAS NOT PROVIDED FOR THE EVENTS BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR BACTERIAL GROWTH AND SEIZURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death| H| O| R DIANEAL PD2