BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2181448 · Received July 27, 2011

    Report

    Report Number
    1423500-2011-09822
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER REVIEW, THE ALLEGATION OF "HUMIDITY ON THE BAG AND THE SOLUTION WAS BLURRY" INVOLVES THE DRUG BAG; THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE PRODUCT CODES 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 WAS NOT REQUESTED. 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. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, BAXTER (B)(4) RECEIVED A REPORT FROM THE HOME PATIENT (HP) THAT ON AN UNKNOWN DATE IN (B)(6) 2011, THEY NOTED A LEAK IN A SOLUTION BAG BUT DID NOT USE IT. A SECOND BAG WAS NOTED TO HAVE HUMIDITY ON THE BAG AND THE SOLUTION WAS BLURRY, HOWEVER THE HP USED THE SECOND BAG ON (B)(6) 2011. ON THE SAME NIGHT, THE HP EXPERIENCED DIARRHEA MANIFESTED BY ABDOMINAL PAIN AND WAS HOSPITALIZED THAT DAY AND DIAGNOSED WITH PERITONITIS. TREATMENT INITIATED (B)(6) 2011 WAS INTRAPERITONEAL (IP) VANCOMYCIN 1GM INITIALLY, THEN EVERY THREE DAYS, AND INTRAVENOUS (IV) ROCEPHIN 2GG FOR 1 DOSE. AT THE TIME OF THIS REPORT, THE HP REMAINED HOSPITALIZED AND THE PERITONITIS WAS NOT RESOLVED. THE PATIENT OUTCOME FOR THE EVENT WAS UNKNOWN AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R ROCALTROL| LIPITOR| HOME CHOICE| PHOSEX| CORASPIN| EXTRANEAL VIAFLEX