BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1951207 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00185
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    January 1, 2010
    Report Date
    December 17, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN

    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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT DONE BY A PHYSICIAN FROM (B)(6) OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6), NON-ASEPTIC TECHNIQUE OF CATHETER HANDLING, AND FEVER IN A (B)(6) MALE COINCIDENT WITH DIANEAL PD4 UNKNOWN BAG THERAPY. ON (B)(6) 2009, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 UNKNOWN BAG (4L DAILY AND 5L TWICE DAILY, LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND FEVER. ON AN UNREPORTED DATE, THE PHYSICIAN CONCLUDED THAT THE PATIENT HAD BACTERIAL PERITONITIS DUE TO NON-ASEPTIC TECHNIQUE OF CATHETER HANDLING. ON AN UNREPORTED DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH KEFZOL (250MG, FREQUENCY AND ROUTE NOT REPORTED). ON (B)(6) 2010, REMEDIAL THERAPY WITH KEFZOL WAS DISCONTINUED. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN PROPER ASEPTIC TECHNIQUE OR WHETHER THE FEVER HAD RESOLVED. DIANEAL PD4 UNKNOWN BAG THERAPY WAS ONGOING. THE PHYSICIAN STATED THAT THE BACTERIAL PERITONITIS WAS NOT RELATED TO DIANEAL PD4 UNKNOWN AND DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENTS OF NON-ASEPTIC TECHNIQUE OF CATHETER HANDLING OR FEVER.

    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 41 YR Required Intervention DIANEAL PD4