BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2395367 · Received January 3, 2012

    Report

    Report Number
    1423500-2012-00089
    Event Type
    Death
    Date Received
    January 3, 2012
    Date of Event
    November 1, 2011
    Report Date
    December 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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 REQUEST. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS INCIDENT. SHOULD ADDITIONAL INFORMATION BECOME 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. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H11H29124 AND H11G24010 WITH NO EXCEPTIONS OBSERVED RELATED TO THE REPORTED CONDITION. THE COMPLAINT WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A NURSE IN THE USA OF NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI), RESPIRATORY FAILURE, PNEUMOPERITONEUM, PERITONITIS WAS CULTURE POSITIVE FOR ESCHERICHIA COLI (E-COLI), PULMONARY EDEMA AND FATAL CARDIAC FAILURE IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN NSTEMI, RESPIRATORY FAILURE, A PNEUMOTHORAX WITH A RESULTING PNEUMOPERITONEUM AND WAS HOSPITALIZED ON (B)(6) 2011 FOR THOSE EVENTS. ON AN UNREPORTED DATE DURING THE HOSPITALIZATION, THE PATIENT EXPERIENCED PERITONITIS, PULMONARY EDEMA AND RESPIRATORY FAILURE. ON AN UNREPORTED DATE, A PERITONEAL EFFLUENT CULTURE WAS OBTAINED AND THE RESULTS WERE POSITIVE FOR ESCHERICHIA COLI. ON AN UNREPORTED DATE AFTER THE RESPIRATORY FAILURE EVENT, THE PATIENT WAS INTUBATED. ON AN UNREPORTED DATE DURING THE HOSPITALIZATION, THE PATIENT DIED. THE CAUSE OF DEATH WAS CARDIAC FAILURE. THE NURSE REPORTED THE EVENT PNEUMOPERITONEUM WAS RELATED TO DIANEAL THERAPY, BUT THE EVENTS OF NON ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI), RESPIRATORY FAILURE, PERITONITIS WITH CULTURE POSITIVE FOR ESCHERICHIA COLI (E-COLI), PULMONARY EDEMA AND FATAL CARDIAC FAILURE WERE NOT RELATED TO DIANEAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| H DIANEAL PD4 AMBUFLEX| HOMECHOICE