BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1864019 · Received October 11, 2010

    Report

    Report Number
    1423500-2010-04299
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 18, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES 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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE (B)(6) OF A BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNKNOWN DATE, A BREAK IN ASEPTIC TECHNIQUE OCCURRED DESCRIBED AS "DID NOT WEAR A MASK." ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY CLOUDY DIALYSATE AND ABDOMINAL PAIN. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010 FOR THE PERITONITIS. THE CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE. ON AN UNKNOWN DATE, THE PATIENT RECEIVED REMEDIAL MEDICATIONS OF GENTAMYCIN (4MG/DL, PDS) AND CIPROFLOXACIN (250MG, Q12, TAB). THE PERITONITIS WAS ONGOING AND IMPROVED. THE OUTCOME FOR THE BREAK IN ASEPTIC TECHNIQUE WAS UNKNOWN. THE REPORTER BELIEVED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO THE PD THERAPY. NO CAUSALITY STATEMENT WAS REPORTED FOR THE BREAK IN ASEPTIC TECHNIQUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R