BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2882010 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07810
    Event Type
    Death
    Date Received
    December 20, 2012
    Date of Event
    November 22, 2012
    Report Date
    December 1, 2012
    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 CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR PERITONITIS-NO DEVICE MALFUNCTION OR USE ERROR IS NOT CONFIRMED BECAUSE DISPOSABLE SET WAS NOT RETURNED TO BAXTER, BATCH REVIEW REVEALED RESULTS ARE ACCEPTABLE WITH NO MANUFACTURING ISSUES AND USER DID NOT DESCRIBE ANY TYPES OF USE ERRORS OR OTHER ISSUES THAT MIGHT HAVE CAUSED THE REPORTED ISSUE. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR H12I05071, H12G18037 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE

    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 IS NOT AVAILABLE. 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, A CARE GIVER CONTACTED BAXTER AND REPORTED THAT HER MOTHER HAD PASSED AWAY. PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) ON (B)(6) 2012 IN ORDER TO OBTAIN ADDITIONAL INFORMATION PERTAINING TO THIS REPORT OF A HOMECHOICE PATIENT'S (HP) DEATH. THE PDRN STATED THAT THE HP HAD BEEN DIAGNOSED WITH PERITONITIS ON (B)(6) 2012. THE HP WAS TREATED WITH CEFAZOLIN AND GENTAMYCIN (DOSE, ROUTE AND FREQUENCIES NOT REPORTED). THE HP WAS THEN HOSPITALIZED WITH PERITONITIS ON (B)(6) 2012. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. TREATMENT IN THE HOSPITAL WAS UNKNOWN. PD THERAPY WAS ONGOING. ON (B)(6) 2012 THE HP PASSED AWAY. THE CAUSE OF DEATH WAS RESPIRATORY ARREST. THE PDRN STATED THAT SHE BELIEVED THE RESPIRATORY ARREST TO BE DUE TO THE PERITONITIS. AN AUTOPSY WAS NOT PERFORMED. IT WAS UNKNOWN IF A DEATH CERTIFICATE WAS AVAILABLE.

    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 80 YR Death| H| R DIANEAL LOW CAL PD4 AMBUFLEX