BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2854650 · Received December 3, 2012

    Report

    Report Number
    1416980-2012-06286
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    September 1, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED FROM A NURSE: THE NURSE CONFIRMED THAT THE PATIENT HAD THE SAME ORGANISM ON (B)(6) 2012 AS THEY DID IN (B)(6) 2012. THE PATIENT HAS NOT YET RECOVERED FROM THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN; THEREFORE, MANUFACTURER SITE IS 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 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. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF COLON WAS NICKED AND PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL, THE FOLLOWING WAS REPORTED BY A CONSUMER. ON (B)64) 2012, THE PATIENT WAS HOSPITALIZED FOR AND UNDERWENT A COLONOSCOPY. DURING HOSPITALIZATION THE PATIENT WAS SWITCHED FROM USING THE CYCLER FOR PERITONEAL DIALYSIS THERAPY TO MANUAL SUPPLIES. DURING THE COLONOSCOPY THE PATIENT'S COLON WAS NICKED. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH GENTAMYCIN AND CEFAZOLIN FOR 14 DAYS. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2012, THE PATIENT HAD CLOUDY EFFLUENT AND WAS HOSPITALIZED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM HOSPITAL. ON (B)(6) 2012, THE PATIENT HAD CLOUDY EFFLUENT AGAIN. THE PATIENT WAS NOT HOSPITALIZED AND WAS CONTINUED ON THE SAME TREATMENT WITH CEFAZOLIN AND GENTAMYCIN. ON (B)(6) 2012, THE PATIENT STOPPED TREATMENT WITH GENTAMYCIN AND CONTINUED WITH A INCREASED DOSE OF CEFAZOLIN FOR 25 MORE DAYS. ON (B)(6) 2012, THE PATIENT SWITCHED BACK FROM MANUAL SUPPLIES TO THE CYCLER TO PERFORM PD THERAPY AND IS ADDING ANTIBIOTICS TO THE LAST FILL. THE OUTCOME OF THIS PERITONITIS EVENT WAS NOT REPORTED. PER THE PATIENT, THE PERITONITIS WAS NOT RELATED TO BAXTER PRODUCTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXTRANEAL 7.5% PD2| UNKNOWN HYPERTENSION MEDICATION| DIANEAL 1.5% PD4| HOMECHOICE| DIANEAL 2.5% PD4