BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2912014 · Received January 11, 2013

    Report

    Report Number
    1416980-2013-00950
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 21, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A SAMPLE IS NOT REQUIRED FOR USE ERROR AS THERE IS NO ALLEGATION AGAINST THE DEVICE. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WAS NOT PERFORMED. THIS REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE IS CONFIRMED BECAUSE THE NURSE REPORTED THERE WAS A BREAK IN ASEPTIC TECHNIQUE DUE TO ACCIDENTAL CONTAMINATION FROM THE ENVIRONMENT, IN WHICH THE PATIENT WAS PERFORMING PD THERAPY IN, WHILE CAMPING. HOWEVER, THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION FROM A NURSE OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL THERAPY FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2012, DURING A CALL WITH BAXTER CUSTOMER SERVICES THE PATIENT REPORTED THE FOLLOWING INFORMATION. ON AN UNREPORTED DATE, THE PATIENT'S BELT PINCHED WHEN THE PATIENT BENT OVER WHICH PROGRESSED UNDERNEATH THE SKIN AND BEGAN TO CLEAR UP AND THEN BECAME "COMPLICATED". ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS RELATED TO THE ISSUE WITH THE PINCHED BELT. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. TREATMENT WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, PERITONEAL DIALYSIS (PD) THERAPY WAS WITHDRAWN. THE PATIENT WAS RECOVERING FROM THE PERITONITIS EVENT. ON (B)(6) 2013, PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE REGARDING THE PERITONITIS EVENT. THE FOLLOWING INFORMATION WAS REPORTED. ON AN UNKNOWN DATE, APPROXIMATELY 2 YEARS AGO, THE PATIENT BEGAN AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE NURSE STATED THAT PD THERAPY WAS NOT WITHDRAWN AS A RESULT OF THIS EVENT AS PREVIOUSLY REPORTED. PD THERAPY WAS ONGOING. ON AN UNKNOWN DATE IN (B)(6) 2012, THE PATIENT PERFORMED PERITONEAL DIALYSIS (PD) THERAPY WHILE CAMPING. IN (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR THE EVENT (EXACT DATES WERE UNKNOWN). THE CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE DUE TO ACCIDENTAL CONTAMINATION FROM THE ENVIRONMENT, IN WHICH THE PATIENT WAS PERFORMING PD THERAPY IN, WHILE CAMPING. THE NURSE INDICATED THE PATIENT WAS USUALLY VERY CAREFUL WHEN USING ASEPTIC TECHNIQUE TO PERFORM PD THERAPY. THE NURSE COULD NOT CONFIRM THE EVENT OF ?PATIENT'S BELT PINCHED WHEN THE PATIENT BENT OVER WHICH PROGRESSED UNDERNEATH THE SKIN AND BEGAN TO CLEAR UP AND THEN BECAME COMPLICATED,? STATING SHE WAS UNAWARE OF THIS ISSUE. THE PATIENT WAS TREATED WITH GENTAMICIN AND FORTAZ (ROUTE, DOSAGE, FREQUENCY WERE NOT REPORTED). ON AN UNREPORTED DATE, THE EVENT OF PERITONITIS RESOLVED. ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED TO WEAR GLOVES AND PERFORM THERAPY IN A CLEAN ENVIRONMENT, IF PERFORMING PD THERAPY WHILE CAMPING, IN THE FUTURE. THE NURSE STATED THE PERITONITIS EVENT WAS UNRELATED TO ANY BAXTER PD SOLUTIONS, DISPOSABLES OR DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18633 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R HOMECHOICE| DIANEAL LOW CALCIUM AMBUFLEX