BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1813276 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02843
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 2, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS OPENED TO ADDRESS A PATIENT REACTION OF PERITONITIS. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE RELATED TO USE ERROR - POOR ASEPTIC TECHNIQUE. USER FAILURE IN ASEPTIC TECHNIQUE IS A KNOWN CAUSE FOR PERITONITIS AND PRODUCT LABELING INCLUDES WARNINGS AND INSTRUCTIONS REGARDING THE PROPER USE OF ASEPTIC TECHNIQUE TO AVOID PERITONITIS. NO PRODUCT DEFECTS WERE REPORTED AS POTENTIAL CAUSES FOR THE PERITONITIS AND NO SAMPLES WERE AVAILABLE FOR EVALUATION. THE LOT NUMBER WAS UNKNOWN, SO NO BATCH REVIEW WAS PERFORMED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THIS COMPLAINT. 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

    ON (B)(6) 2010, THE CUSTOMER CALLED BAXTER (B)(4) TECHNICAL SERVICES FOR A TINA DEVICE HAVING A WET VENOUS TRANSDUCER PROTECTOR. PATIENT INJURY/MEDICAL INTERVENTION WAS NOT REPORTED. THE BAXTER TECHNICIAN ADVISED THE BAXTER FIELD SERVICE TECHNICIAN TO GO ONSITE TO REPAIR THE DEVICE. AS SUCH, THE DEVICE WILL NOT BE RETURNED TO (B)(4) TECHNICAL SERVICES.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A NURSE FROM VIETNAM OF BREAK IN ASEPTIC TECHNIQUE (CODED AS PERITONEAL DIALYSIS COMPLICATION), PERITONITIS, AND FEVER IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6)2010, THE PATIENT DEVELOPED PERITONITIS MANIFESTED BY ABDOMINAL PAIN, CLOUDY EFFLUENT, AND FEVER. ON AN UNREPORTED DATE, THE PATIENT BEGAN UNSPECIFIED ANTIBIOTICS. PD THERAPY WAS ONGOING. THE PERITONITIS WAS RESOLVING. IT WAS UNKNOWN WHETHER THE BREAK IN ASEPTIC TECHNIQUE AND FEVER RESOLVED. ON (B)(6)2010, THE PATIENT WAS DISCHARGED. ON AN UNREPORTED DATE, THE PERITONITIS RESOLVED.

    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 45 YR Hospitalization| R DIANEAL UNKNOWN BAG