BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1823381 · Received September 2, 2010

    Report

    Report Number
    1423500-2010-03093
    Event Type
    Injury
    Date Received
    September 2, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 10, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. A LABELING REVIEW WAS CONDUCTED AND FOUND TO BE ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT.

    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 EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Description of Event or Problem · 1

    DURING LAP CHOLE PROCEDURE, PHYSICIAN WAS USING FOOT PEDAL CAUTERY - STATED IT WAS NOT WORKING PROPERLY. ALL EQUIPMENT CHECKED AND THERE WAS NO REASON WHY EQUIPMENT WOULD NOT WORK. THEN A SPARK AND FLAME JUMPED UP AT THE JOINT OF CORD. DR EXTINGUISHED THE FLAME - NO INJURY TO PT - CORD WAS BURNED COMPLETELY THROUGH. DATES OF USE: (B)(6)2010. DIAGNOSIS OR REASON FOR USE: SURGERY.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS. ON (B)(6) 2010, THE PATIENT STARTED PERITONEAL DIALYSIS TREATMENT. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010. ON (B)(6) 2010, A PERITONEAL EFFLUENT ANALYSIS WAS PERFORMED. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH REFLIN (1GM, DAILY, IP) AND TOBRAMYCIN (40MG, DAILY, IP). DIANEAL THERAPY WAS ONGOING AS WELL AS REMEDIAL THERAPY WITH REFLIN AND TOBRAMYCIN. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. NO CONCOMITANT MEDICATIONS WERE REPORTED. THE NURSE BELIEVED THAT THE PERITONITIS WAS NOT RELATED TO PERITONEAL DIALYSIS THERAPY.

    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 Hospitalization| R