BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3913357 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21481
    Event Type
    Death
    Date Received
    July 3, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). TREATMENT FOR SEPSIS WAS NOT REPORTED. THE NURSE CLARIFIED THAT THE PATIENT'S FLUIDS SHE PREVIOUSLY REPORTED CLEARING UP PRIOR TO DEATH WERE THE PATIENT'S PERITONEAL EFFLUENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED BACTERIAL PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE SAME DAY AS ONSET THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) VANCOMYCIN (210MG DAILY FOR 5 DAYS) AND IP GENTAMICIN (70 MG DAILY FOR 5 DAYS). FIVE DAYS AFTER ONSET, THE PATIENT WAS TREATED WITH IP ROCHEPHIN (1500MG DAILY, WITH AN UNREPORTED END DATE). THE CAUSE OF THE PERITONITIS WAS A BREACH IN ASEPTIC TECHNIQUE, FURTHER DESCRIBED AS ¿THE PATIENT DISCONNECTED HERSELF AND CONTAMINATED HERSELF¿. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED 15 DAYS AFTER THE ONSET OF THE PERITONITIS EVENT FOR ¿BEING UNRESPONSIVE¿. THE SAME DAY, THE PATIENT WAS PLACED ON A VENTILATOR DUE TO WEAK RESPIRATIONS AND LOW BLOOD PRESSURE. THE FOLLOWING DAY, THE PATIENT DEVELOPED A FEVER. WHILE HOSPITALIZED, THE PATIENT WAS DIAGNOSED WITH SEPSIS. TWO DAYS AFTER HOSPITAL ADMISSION, THE PD CATHETER WAS REMOVED AND HEMODIALYSIS WAS INITIATED. FOUR DAYS AFTER ADMISSION, THE PATIENT PASSED AWAY. IT WAS UNKNOWN IF THE PERITONITIS HAD RESOLVED PRIOR TO DEATH. IT WAS REPORTED THE PATIENT WAS STILL BEING TREATED WITH ANTIBIOTICS FOR THE PERITONITIS EVENT WHILE HOSPITALIZED. THE CAUSE OF DEATH WAS REPORTED AS SEPSIS. THE DOCTOR REPORTED THE CAUSE OF THE SEPSIS WAS SAID NOT TO BE RELATED TO THE PERITONITIS. THE PD NURSE REPORTED THE PATIENT¿S FLUID WAS CLEARING UP PRIOR TO DEATH. THE CAUSE OF THE SEPSIS WAS UNDETERMINED. IT WAS REPORTED AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389716 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| H| R HOMECHOICE, DIANEAL PD2 1.5% AND 2.5% SOLUTIONS