BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1963902 · Received January 19, 2011

    Report

    Report Number
    1423500-2011-00768
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    November 1, 2010
    Report Date
    January 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF THIS PERITONITIS EPISODE IS UNKNOWN, AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION. THIS IS THE SECOND OF FOUR COMPLAINTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H10H07014, H10G02025 AND H10G12115 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. ROOT CAUSE COULD NOT BE DETERMINED BASED ON INFORMATION AVAILABLE IN THIS COMPLAINT REPORT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(4) 2011 THE HOME PATIENT(HP), WHILE ON AN UNRELATED CALL WITH BAXTER, STATED THAT SHE HAD AN INFECTED PERITONEAL DIALYSIS(PD) CATHETER. ON (B)(6) 2011, THE HP'S DIALYSIS NURSE (PDRN) STATED ON (B)(6) 2010 THE HP COMPLAINED OF ABDOMINAL PAIN AND CLOUDY PD EFFLUENT. THE PDRN INSTRUCTED HER TO COME TO THE CLINIC WHERE PD EFFLUENT WAS CULTURED. THAT DAY, THE HP WAS GIVEN LOADING DOSES OF ANCEF AND FORTAZ, BOTH 2GM DOSAGES INTRAPERITONEALLY (IP), THEN CONTINUED THE ANCEF AND FORTAZ BOTH 1GM, IP, DAILY. THE HP REMAINED ON IP ANCEF AND FORTAZ (SAME DOSAGES) UNTIL (B)(6) 2010, WHEN SHE WAS RECULTURED. WHEN THE CULTURE RESULTS WERE UNCHANGED FROM THE (B)(6) 2010 RESULTS, THE ANTIBIOTICS WERE CONTINUED. THE HP STARTED NYSTATIN PROPHYLACTICALLY FOR FUNGAL INFECTION. THE INFECTION WAS THOUGHT TO ORIGINATE IN THE PD CATHETER, AND A SURGICAL CONSULTATION WAS SCHEDULED FOR (B)(6) 2010 FOR IT'S REMOVAL. SHE HAS RECEIVED PERITONEAL DIALYSIS(PD) SINCE (B)(6) 2008 AND CONTINUES WITH THE HOME CHOICE CYCLER USING LOCAL PD4 AMBUFLEX. THE PDRN STATED THAT NONE OF THE BAXTER PRODUCTS ARE SUSPECT. ACCORDING TO THE PDRN, CAUSALITY IS THE HP'S WELL WATER WHICH IS NOT CHEMICALLY TREATED. THE PDRN STATED THAT THE HP HAS BEEN INSTRUCTED TO NOT DRINK OR BATHE WITH THE WATER DUE TO THE INFECTION RISKS. THE PDRN WAS UNAWARE IF THE WATER HAD BEEN TESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention HOME CHOICE CYCLER| LOCAL PD4 AMBUFLEX| NYSTATIN