BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3886928 · Received June 20, 2014

    Report

    Report Number
    1416980-2014-19705
    Event Type
    Death
    Date Received
    June 20, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FOLLOW UP IT WAS REPORTED THAT THE PATIENT EXPERIENCED ¿OAP¿ (UNSPECIFIED MEDICAL CONDITION). THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR THE PERITONITIS. TWELVE DAYS AFTER BEING ADMITTED TO THE HOSPITAL FOR PERITONITIS, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE FOLLOWING MONTH, THE PATIENT PASSED AWAY WHILE IN THE HOSPITAL DUE TO ¿OAP¿ AND PERITONITIS. ANTIBIOTIC AND DIANEAL THERAPIES WERE ONGOING UNTIL THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FOLLOW UP, THE CAUSE OF DEATH REPORTED AS "OAP" WAS FURTHER SPECIFIED AS OEDEMA AND ACUTE PNEUMONIA. TREATMENT PRIOR TO DEATH WAS NOT REPORTED. THE PATIENT HAD BEEN DOING MANUAL EXCHANGES FOR PERITONEAL DIALYSIS PRIOR TO PASSING AWAY. AN AUTOPSY WAS NOT PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED AS CLOUDY PD FLUIDS AND ABDOMINAL PAIN. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON THE SAME DAY AS THE ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT FOR THE EVENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED AND WAS NOT RECOVERED FROM THE PERITONITIS EVENT. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363806 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R DIANEAL PD4 1.5 % AND 2.5%