BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4222221 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38629
    Event Type
    Death
    Date Received
    November 3, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 9, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    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 REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT DIED COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF DEATH WAS RESPIRATORY ARREST. ON AN UNREPORTED DATE, THE PATIENT RECEIVED TREATMENT FOR PERITONITIS WITH VANCOMYCIN (DOSE, ROUTE AND FREQUENCY NOT REPORTED). IT WAS NOT REPORTED WHETHER THE PATIENT RECOVERED FROM THE PERITONITIS PRIOR TO DEATH. ON AN UNREPORTED DATE, THE PATIENT WAS TRANSITIONED TO HOSPICE CARE AND WAS DISCHARGED TO HOME. SUBSEQUENTLY THE PATIENT PASSED AWAY AT HOME. DIANEAL THERAPIES WERE ONGOING UNTIL THE TIME OF DEATH. IT WAS REPORTED THAT THE PATIENT HAD DISCONNECTED FROM THE BAXTER HOME CHOICE AT 6:00 AM ON THE DATE OF DEATH, AND THEN PASSED AWAY AT 10:40 AM. THE HOME PATIENT WAS A DO NOT RESUSCITATE (DNR) STATUS PRIOR TO DEATH. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) WHICH CAUSED PERITONITIS. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT BECAME CONFUSED, DISCONNECTED AT NIGHT FROM THE HOMECHOICE, AND CAUSED A CONTAMINATION. THE PERITONITIS WAS MANIFESTED BY NAUSEA, VOMITING, AND CLOUDY EFFLUENT. TWO DAYS AFTER ONSET, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. BEGINNING THE DAY OF ONSET, THE PATIENT WAS TREATED WITH GENTAMYCIN INTRAPERITONEALLY (DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH AN UNSPECIFIED ORAL ANTIBIOTIC (MEDICATION, DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE PERITONITIS EVENT. DIANEAL THERAPIES WERE ONGOING. ON AN UNREPORTED DATE DURING THE HOSPITALIZATION, THE PERITONEAL DIALYSIS CATHETER WAS REMOVED AND REPLACED. AFTER TWENTY DAYS OF HOSPITALIZATION, THE PATIENT WAS DISCHARGED. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENTS¿ CAREGIVER WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702871 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death| H| R DIANEAL 1.5% AND 2.5% LOW CALCIUM SINGLEBAG| MINICAP, CASSETTE| DIANEAL PD4, 2.5% ULTRABAG| HOMECHOICE, TRANSFER SET, TITANIUM ADAPTER