BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4243521 · Received November 11, 2014

    Report

    Report Number
    1416980-2014-39910
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    September 23, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE, COINCIDENT WITH PERITONEAL DIALYSIS THERAPY, WHICH LED TO BACTERIAL PERITONITIS. THIS WAS RELATED TO PATIENT¿S PERSONAL HYGIENE ISSUES AND IT WAS NOTED THAT THE PATIENT WAS NOT ALWAYS PUTTING MINICAPS ON WHEN DISCONNECTING AND RECONNECTING TO GO TO THE BATHROOM. THE CAREGIVER STATED THAT THE ONSET OF PERITONITIS WAS NOTICED WHEN THE PATIENT BEGAN SHAKING WITH FEVER AND HAD ABDOMINAL PAIN. AFTER CHECKING THE DRAIN BAG, THE CARE GIVER SAW THAT IT HAD A CLOUDY/MUDDY APPEARANCE. THE PATIENT WAS HOSPITALIZED FOR THE REPORTED EVENT. IT WAS REPORTED THAT THE PATIENT¿S FEVER/SYMPTOMS HAD BROKEN THE FOLLOWING DAY. THE TREATMENT FOR THE PERITONITIS INCLUDED CEFAZOLIN (1.5GM INTRAPERITONEALLY (IP), DAILY), CEFTAZADIME (1.5MG, IP, DAILY) AND NYSTATIN (500,000 UNITS, FOUR TIMES DAILY FOR 3 WEEKS). THE PATIENT WAS LATER DISCHARGED, HAD COMPLETED THE ANTIBIOTICS AND WAS SAID TO BE FULLY RECOVERED FROM THE REPORTED EVENT. THE PATIENT WAS NOT RETRAINED IN PROPER ASEPTIC TECHNIQUE BECAUSE THEY WERE NO LONGER ALLOWED TO CONNECT/DISCONNECT ON THEIR OWN. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726841 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R DIANEAL 1.5% AND 2.5% AMBUFLEX, EXTRANEAL| HOMECHOICE, MINICAP, TRANSFER SET