BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3760376 · Received April 20, 2014

    Report

    Report Number
    1416980-2014-12764
    Event Type
    Injury
    Date Received
    April 20, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 26, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE FURTHER DESCRIBED AS THE PATIENT NOT WASHING THEIR HANDS PRIOR TO THE START OF PERITONEAL DIALYSIS (PD) THERAPY. FOLLOWING THE BREAK IN THE ASEPTIC TECHNIQUE THE PATIENT HAD CLOUDY PERITONEAL DRAINAGE AND ABDOMINAL PAIN. THE FOLLOWING WEEK, THE PATIENT BEGAN TREATMENT WITH UNSPECIFIED ORAL MEDICATION FOR AN UNKNOWN INDICATION. IN THE FOLLOWING MONTH THE PATIENT WAS HOSPITALIZED FOR CLOUDY PERITONEAL DRAINAGE AND ABDOMINAL PAIN. THE PATIENT WAS DISCHARGED TWO WEEKS AFTER BEING ADMITTED TO THE HOSPITAL. FOUR DAYS LATER, THE PATIENT RETURNED TO THE HOSPITAL FOR CLOUDY PERITONEAL DRAINAGE. AT THE TIME OF THE REPORT, THE PATIENT WAS RECOVERING FROM THE CLOUDY PERITONEAL DRAINAGE AND ABDOMINAL PAIN. PD THERAPY WAS ONGOING. THERE WAS NO PERITONITIS REPORTED AND IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE FOR THE REPORTED SYMPTOMS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239198 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization LOW CALCIUM PD SOLUTION (LACTATE- G2.5%)