BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1849112 · Received September 30, 2010

    Report

    Report Number
    1423500-2010-03945
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    August 1, 2010
    Report Date
    September 6, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE PRODUCT CODE IS UNKNOWN AND THE SAMPLE WAS DISCARDED, THEREFORE NO EVALUATION WAS PERFORMED. THE PRODUCT CODE IS UNKNOWN THEREFORE, NO 510K NUMBER COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS RECEIVED SIMILAR REPORTS AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT FROM (B)(6) OF PERITONITIS IN A MALE PATIENT COINCIDENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY. ON (B)(6)2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD). ON (B)(6)2010, A BAXTER CLINICAL OPERATOR WAS INFORMED ABOUT A PUNCTURED DRAIN BAG THAT WAS DETECTED BY THE PATIENT ONCE HIS THERAPY WAS COMPLETED. ON (B)(6)2010, DIANEAL THERAPY WAS DISCONTINUED. ON (B)(6)2010, 48 HOURS AFTER THE DETECTION OF THE PUNCTURED BAG, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PATIENT WAS TREATED WITH (UNSPECIFIED) ANTIBIOTICS (DOSE AND FREQUENCY NOT REPORTED). THE OUTCOME FOR THE EVENT OF PERITONITIS WAS NOT REPORTED. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF PERITONITIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 2 WEEKS FOLLOWING AN AFIB ABLATION, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL WITH SHOULDER/BACK PAIN AND SHORTNESS OF BREATH. SHORTLY AFTER RE-ADMISSION, THE PATIENT EXPIRED FROM A DOCUMENTED ESOPHAGEAL FISTULA. IT WAS UNCLEAR WHAT MEDICAL INTERVENTION WAS ADMINISTERED. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIANEAL PD2 UNKNOWN BAG