BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1863995 · Received October 11, 2010

    Report

    Report Number
    1423500-2010-04298
    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 (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS WITH GRAM STAIN POSITIVE FOR GRAM NEGATIVE BACILLI IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE IN 2010, 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 ABDOMINAL PAIN AND CLOUDY EFFLUENT. ON (B)(6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THE PERITONITIS. IN (B)(6) 2010, THE PATIENT WAS TREATED WITH CEFAZOLIN 400MG IVF Q8 AND GENTAMICIN 4MG/DL. THE PATIENT'S PD CATHETER WAS REMOVED AND A CATHETER WAS INSERTED FOR HEMODIALYSIS. DUE TO THE REMOVAL OF THE PATIENT'S PD CATHETER, PD THERAPY WAS CONSIDERED WITHDRAWN. AT THE TIME OF REPORTING, THE PATIENT REMAINED HOSPITALIZED. THE EVENT OF PERITONITIS WAS ONGOING AND UNCHANGED. SINCE THERE WAS NO DOCUMENTATION INDICATING THAT THE PATIENT HAD BEEN RETRAINED, THE OUTCOME FOR THE EVENT OF BREAK IN ASEPTIC TECHNIQUE WAS UNKNOWN. THE ROOT CAUSE OF THE PERITONITIS WAS BREAK IN ASEPTIC TECHNIQUE. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO PD. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF 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 16 YR Hospitalization| R