BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1972288 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01153
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 3, 2011
    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. THE ROOT CAUSE FOR THIS INCIDENT IS UNDETERMINED AT THIS TIME. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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 SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF BREAK IN ASEPTIC TECHNIQUE (CODED AS PERITONEAL DIALYSIS COMPLICATION) AND STERILE PERITONITIS IN A (B)(6) MALE PATIENT COINCIDENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY (DOSE AND FREQUENCY NOT REPORTED, INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON AN UNREPORTED DATE IN 2010, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2010, THE PATIENT EXPERIENCED STERILE PERITONITIS, MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT, AND WAS HOSPITALIZED. ON AN UNREPORTED DATE, THE PATIENT BEGAN REMEDIAL THERAPY WITH AMIKACIN (125MG, FREQUENCY AND ROUTE NOT REPORTED). IT WAS NOT REPORTED WHETHER REMEDIAL THERAPY WAS ONGOING. THE NURSE REPORTED THAT THE ROOT CAUSE OF THE STERILE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. DIANEAL PD2 UNKNOWN THERAPY WAS ONGOING. THE EVENT OUTCOME OF STERILE PERITONITIS WAS ONGOING AND IMPROVED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE CONSIDERED THE EVENT OF STERILE PERITONITIS TO BE UNRELATED TO DIANEAL PD2 UNKNOWN BAG THERAPY. THE NURSE DID NOT PROVIDE A CAUSALITY STATEMENT FOR THE EVENT OF A 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 68 YR Hospitalization| R