BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4052115 · Received September 2, 2014

    Report

    Report Number
    1416980-2014-29257
    Event Type
    Death
    Date Received
    September 2, 2014
    Report Date
    August 8, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. THE PATIENT WAS HOSPITALIZED ON AN UNKNOWN DATE IN JUN 2014 TO HAVE SURGERY FOR PVD. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS, SEPSIS, AND SUBSEQUENTLY PASSED AWAY DUE TO CARDIAC ARREST AND SEVERE SEPSIS COINCIDENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. APPROXIMATELY TWO MONTHS PRIOR TO DEATH, THE PATIENT WAS HOSPITALIZED TO HAVE SURGERY FOR ANOTHER INDICATION. TREATMENT DURING HOSPITALIZATION WAS UNKNOWN. APPROXIMATELY ONE MONTH PRIOR TO DEATH, THE PATIENT WAS RECOVERING FROM THE SURGERY AND WAS TRANSFERRED FROM HOME TO A REHABILITATION HOSPITAL. ON AN UNREPORTED DATE ,DURING REHABILITATION, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN, FURTHER DESCRIBED AS ¿COULD HAVE COME FROM THE PATIENT¿S FOOT INFECTION/AMPUTATION IN WHICH HE HAD RECENTLY BEEN HOSPITALIZED FOR.¿ THE PATIENT WAS TREATED WITH INTRAVENOUS DAPTOMYCIN, UNKNOWN DOSE AND FREQUENCY. THE PATIENT WAS PERFORMING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS THERAPY PRIOR TO DEATH AND WAS NOT PERFORMING APD (AUTOMATED PD). TWO DAYS PRIOR TO DEATH, PD THERAPY WAS DISCONTINUED AND HEMODIALYSIS WAS INITIATED. SUBSEQUENTLY THE PATIENT PASSED AWAY. THE PERITONITIS DID NOT RESOLVE PRIOR TO DEATH AS THE ¿DEATH CERTIFICATE STATED SEVERE SEPSIS.¿ THE PATIENT¿S PERITONEAL EFFLUENT CONTINUED TO BE CLOUDY UNTIL DEATH. AN AUTOPSY WAS NOT PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533302 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R TITANIUM ADAPTER & MINICAP| DIANEAL PD4, 1.5% & 2.5% ULTRABAG