BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1984299 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01756
    Event Type
    Death
    Date Received
    February 10, 2011
    Date of Event
    May 1, 2010
    Report Date
    January 18, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ROOT CAUSE COULD NOT BE DETERMINED BASED ON INFORMATION AVAILABLE IN THIS COMPLAINT REPORT.

    Additional Manufacturer Narrative · 1

    (B)(5) - 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. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A NURSE FROM (B)(6). IN (B)(6) 2010, THE PATIENT CHANGED PERITONEAL DIALYSIS (PD) THERAPY TO DIANEALPD1 AND EXTRANEAL VIAFLEX INTRAPERITONEALLY (IP). ON (B)(6) 2010, THE PATIENT EXPERIENCED CLOUDY EFFLUENT AND WAS HOSPITALIZED. WHILE HOSPITALIZED, THE PATIENT HAD ALTERNATING CONSTIPATION AND DIARRHEA EPISODES WITH VOMITING. THE PD EFFLUENT WAS NOT CULTURED, BUT THE PATIENT WAS DIAGNOSED WITH PERITONITIS. TREATMENT WAS WITH IP CEFACIDAL, CEFTRIAXONE, GENTALLINE AND VANCOMYCIN (DOSES, FREQUENCY, AND DURATION NOT REPORTED), AND ON (B)(6) 2010, WAS DISCHARGED. ON (B)(6) 2010, SHE WAS READMITTED FOR SEVERE DETERIORATION, ASTHENIA, ANOREXIA, LOSS OF AUTONOMY AND VOMITING, AND AGAIN DIAGNOSED WITH BACTERIAL PERITONITIS. DURING THE WEEKS PRIOR, THE PATIENT HAD PROBLEMS PERFORMING PD THERAPY, EXPERIENCING LEAKAGE AT THE LEVEL OF THE LINE, DIFFICULTY CONNECTING AND SPIKING, BENT SPIKES, ALARMS AND UNSPECIFIED CONTAMINATION. REPORTEDLY, THE PATIENT'S NEIGHBOR, WHO ASSISTED HER, HAD BEEN DIAGNOSED POSITIVE FOR ESBL IN HER URINE. THE HOSPITAL GAVE CAUSALITY OF THE BACTERIAL PERITONITIS TO CROSS CONTAMINATION FROM THE NEIGHBOR. TREATMENT INCLUDED GENTALLINE AND CLAFORAN (B)(6) 2010. ON (B)(6) 2010, TREATMENT CHANGED TO TIENAM AND AMIKACIN (ALL DOSE AND DURATIONS NOT REPORTED). ON (B)(6) 2010, THE PATIENT'S STATUS WORSENED. ON (B)(6) 2010, AFTER EXPERIENCING PULMONARY CONGESTION, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT REPORTED. NO AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF DIANEAL PD1 AND EXTRANEAL VIAFLEX THERAPIES WERE ONGOING AT THE TIME OF THE DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| H| O| R KARDEGIC| SOTALOL| PARACETAMOL| DIANEAL PD1| EPOETINE ALFA| EXTRANEAL VIAFLEX| OMEPRAZOLE