BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2943981 · Received February 5, 2013

    Report

    Report Number
    1416980-2013-02963
    Event Type
    Death
    Date Received
    February 5, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 11, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - BREACH IN ASEPTIC TECHNIQUE ISSUE AND PATIENT WHO SUBSEQUENTLY ACQUIRED PERITONITIS AND PASSED AWAY. COMPLAINT IS CONFIRMED BECAUSE IT WAS REPORTED THAT THE PATIENT MADE TOUCH CONTAMINATION AND FOLLOWED POOR TECHNIQUE WHICH WAS FURTHER EXPLAINED AS THE PATIENT HAD CONNECTED INCORRECTLY, AND DID NOT PUT THE CAP ON THE CATHETER AND LEFT THE CATHETER HANGING. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY.

    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 IS NOT AVAILABLE. 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. SHOULD RELEVANT 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION FROM A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPIES. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG THERAPY INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION, SEPSIS, AND PERITONITIS. TREATMENT WAS NOT REPORTED. ON (B)(6) 2013, THE PATIENT DIED DUE TO MYOCARDIAL INFARCTION, SEPSIS, AND PERITONITIS. IT WAS NOT REPORTED WHETHER OR NOT AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED FROM A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES, IP, FOR PD. THE PATIENT WAS NOT CONNECTED TO THE HOMECHOICE MACHINE, NOR RECEIVING DIANEAL AT THE TIME OF DEATH. ON AN UNREPORTED DATE, THE PATIENT HAD RECONNECTED HER PD SUPPLIES WITHOUT FIRST STERILIZING. ON AN UNREPORTED DATE, THE PATIENT HAD TOUCH CONTAMINATION AND FOLLOWED POOR TECHNIQUE, WHICH WAS FURTHER EXPLAINED AS THE PATIENT HAD CONNECTED INCORRECTLY, DID NOT PUT THE CAP ON THE CATHETER, AND LEFT THE CATHETER HANGING. THE PATIENT DID NOT CALL HER PD CLINIC TO INFORM THEM OF HER NOT CONNECTING CORRECTLY, NOT PUTTING THE CAP ON HER CATHETER, AND LEAVING THE CATHETER HANGING. ON AN UNREPORTED DATE IN (B)(6) 2012, THE PATIENT EXPERIENCED DIARRHEA, NAUSEA, AND VOMITING. ON AN UNREPORTED DATE IN (B)(6) 2012, THE DAY AFTER THE PATIENT EXPERIENCED DIARRHEA, NAUSEA, AND VOMITING, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND CLOUDY FLUID. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR E. COLI PERITONITIS. THE CAUSE OF THE PERITONITIS WAS POOR TECHNIQUE/TOUCH CONTAMINATION. IT WAS NOT REPORTED IF RETRAINING ON PROPER ASEPTIC TECHNIQUE WAS PERFORMED. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH GENTAMYCIN, IP (DOSE AND FREQUENCY NOT REPORTED), AND ORAL LEVAQUIN (DOSE AND FREQUENCY NOT REPORTED). ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TO A SKILLED NURSING FACILITY. ON AN UNREPORTED DATE, THE PATIENT DID NOT WIPE HERSELF WELL AFTER GOING TO THE BATHROOM. ON (B)(6) 2013, THE PATIENT WAS AGAIN ADMITTED TO THE HOSPITAL AFTER THE PATIENT BECAME CONFUSED DUE TO A MEDICATION ISSUE. DURING HOSPITALIZATION, THE PATIENT WAS DIAGNOSED WITH UROSEPSIS. PER THE NEPHROLOGIST'S NOTES, ON (B)(6) 2013, THE PATIENT EXPERIENCED RELAPSING E. COLI PERITONITIS. ON (B)(6) 2013, IT WAS DISCUSSED WITH THE PATIENT AND FAMILY THAT THE PATIENT'S PD CATHETER WOULD BE REMOVED, WITH THE PLAN FOR A PERMANENT CATHETER TO BE PLACED FOR HEMODIALYSIS. ON (B)(6) 2013, THE PLAN WAS CHANGED AND THE PATIENT WAS PLACED IN HOSPICE CARE THAT AFTERNOON. ON (B)(6) 2013, THE PATIENT DIED. THE PDRN COULD NOT CONFIRM THE CAUSE OF DEATH. THE PATIENT'S DAUGHTER HAD TOLD THE SOCIAL WORKER THAT THE CAUSE OF DEATH WAS "HEART FAILURE". IT WAS UNKNOWN TO THE PDRN IF THE PATIENT HAD EXPERIENCED A MYOCARDIAL INFARCTION OR IF THE PATIENT'S HEART HAD JUST GIVEN OUT. A DEATH CERTIFICATE WAS NOT AVAILABLE TO THE PD CLINIC AT THE TIME OF THIS REPORT. AT THE TIME OF DEATH, THE E. COLI PERITONITIS WAS NOT RESOLVED AND THE UROSEPSIS WAS ONGOING. THE OUTCOME OF THE PATIENT CONFUSION, DIARRHEA, NAUSEA, VOMITING, ABDOMINAL PAIN AND CLOUDY FLUID EVENTS WAS NOT REPORTED. THE PDRN CONSIDERED THE DIARRHEA, NAUSEA, VOMITING, ABDOMINAL PAIN, CLOUDY FLUID, AND PERITONITIS EVENTS TO BE UNRELATED TO THE DIANEAL SOLUTION, HOMECHOICE MACHINE, AND ANY DISPOSABLE PARTS. SHE DID CONSIDER THE EVENTS TO BE RELATED TO "TOUCH CONTAMINATION." THE CONFUSION WAS RELATED TO MEDICATION AND THE UROSEPSIS WAS CAUSED BY THE PATIENT NOT WIPING HERSELF WELL AFTER GOING TO THE BATHROOM. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48008 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death| H| R DIANEAL PD4 AMBUFLEX| HOMECHOICE| DIANEAL PD4 ULTRABAG