BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2950906 · Received February 8, 2013

    Report

    Report Number
    1416980-2013-03358
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 16, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBERS H12F26099 AND H12H21013 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE REPORTED PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A NURSE IN THE USA OF PERITONITIS WHICH OCCURRED IN A HOME PATIENT (HP) ON PERITONEAL DIALYSIS (PD) THERAPY. THE HP PERFORMS PD THERAPY WITH DIANEAL PD2 AMBUFLEX (12 LITERS NIGHTLY), INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). RECENTLY, EXTRANEAL VIAFLEX (2 LITERS NIGHTLY), IP, WAS ADDED TO THE PATIENT'S PD THERAPY. THE NURSE REPORTED THE PATIENT HAD BACTERIAL PERITONITIS MANIFESTED BY ABDOMINAL PAIN. THE PATIENT WAS TREATED FOR THE PERITONITIS WITH ANCEF AND FORTAZ FOR 7 DAYS (DOSES, FREQUENCIES, AND LOTS NOT REPORTED). DURING THIS TIME, THE PATIENT REPORTED ALSO HAVING HAND PAIN WITH THE SKIN ON THE PALMS OF HIS HANDS BEING DRY AND FLAKING OFF (FLAKING SKIN TO BILATERAL PALMS AND BILATERAL HAND PAIN). TREATMENT WITH THE ANCEF AND FORTAZ WAS ENDED. NEW TREATMENT FOR THE PERITONITIS WAS INITIATED WITH TOBRAMYCIN, 40MG, IP, DAILY, TO CONTINUE FOR 14 DAYS TOTAL AND ORAL CIPRO, 500MG, DAILY (LENGTH OF TREATMENT NOT REPORTED). THERAPY WITH EXTRANEAL WAS TEMPORARILY STOPPED DUE TO THE HAND PAIN AND FLAKING SKIN. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS AND DIANEAL THERAPY WAS ONGOING. CONCOMITANT MEDICATION WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE EVENTS OF HAND PAIN, SKIN ON THE PALMS OF HANDS DRY AND FLAKING OFF HAD RESOLVED. EXTRANEAL WAS RESTARTED WITH NO FURTHER ISSUES. THE NURSE REPORTED THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE NURSE REPORTED THE PATIENT WAS COUNSELED ON PROPER ASEPTIC TECHNIQUE; HOWEVER, THE PATIENT HAD NOT YET HAD FORMAL RE-TRAINING. THE NURSE REPORTED THE PERITONITIS, HAND PAIN, AND SKIN ON THE PALMS OF HANDS DRY AND FLAKING OFF, WERE NOT RELATED TO A BAXTER DEVICE OR SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54387 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention DIANEAL PD2 AMBUFLEX| EXTRANEAL VIAFLEX