BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2152145 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08737
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS REPORTED BY A PHYSICIAN THE PATIENT TOOK PART IN THE FOLLOWING STUDY: (B)(4), SPONSORED BY BAXTER HEALTHCARE. ON (B)(6) 2011, INVESTIGATIONAL THERAPY WITH DIANEAL PD2 WAS COMPLETED. THE INVESTIGATOR CONSIDERED THE EVENT OF PERITONITIS TO BE UNRELATED TO THE TRIAL PROCEDURE. 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 MDR 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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL AND CORRECTED INFORMATION WAS RECEIVED ON (B)(6) 2011. IT WAS CLARIFIED THAT THE SUBJECT WAS HOSPITALIZED ON (B)(6) 2011 (PREVIOUSLY REPORTED AS (B)(6) 2011). ON (B)(6) 2011, THE SUBJECT BEGAN TREATMENT WITH CEFAZOLIN (1G, IP, DAILY), AMIKACIN (100 MG, IP, EVERY DAY), FUROSEMIDE (20 MG IV SINGLE DOSE AS A DIURETIC), RANITIDINE (50 MG, IV 2X A DAY AS GASTRITIS MANAGEMENT), AND MORPHINE (3 MG IV, SINGLE DOSE FOR PAIN MANAGEMENT). ON (B)(6) 2011, TREATMENT WITH RANITIDINE WAS DISCONTINUED. ON (B)(6) 2011, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2011, TREATMENT WITH AMIKACIN WAS DISCONTINUED. ON (B)(6) 2011, TREATMENT WITH CEFAZOLIN WAS DISCONTINUED. ON (B)(6) 2011, THE SUBJECT RECOVERED FROM THE PERITONITIS. THE SUBJECT WAS STABLE, WITH CLEAR PERITONEAL LIQUID, A SOFT AND DEPRESSIBLE ABDOMEN, AND NO PAIN ON PALPATION.

    Description of Event or Problem · 1

    THIS IS A CLINICAL REPORT BY A PHYSICIAN OF PERITONITIS IN A (B)(6) PATIENT, (HEIGHT (B)(6)) COINCIDENT WITH DIANEAL PD2 THERAPY. ON AN UNREPORTED DATE, THE SUBJECT BEGAN DIANEAL PD2 THERAPY (DOSE, FREQUENCY, AND LOT NUMBER NOT REPORTED), INTRAPERITONEALLY FOR PERITONEAL DIALYSIS. ON (B)(6) 2011, THE SUBJECT EXPERIENCED STRONG ABDOMINAL PAIN. SINCE IT WAS NOT CONTINUOUS, THE SUBJECT DID NOT SEEK EMERGENCY CARE UNTIL (B)(6) 2011 WHEN THE ABDOMINAL PAIN HAD BECOME STRONGER. THE PERITONEAL EFFLUENT WAS CLEAR, BUT THE SUBJECT WAS HOSPITALIZED ON (B)(6) 2011 FOR PERITONITIS. TREATMENT RENDERED FOR THE PERITONITIS WAS NOT REPORTED. THE PERITONITIS WAS RESOLVING. THE INVESTIGATOR CONSIDERED THE PERITONITIS SEVERE AND NOT ASSOCIATED WITH DIANEAL PD2.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R BISACODYL| LOSARTAN| CALCITRIOL| ERYTHROPOIETIN| B COMPLEX| CALCIUM CARBONATE| VERAPAMIL| FOLIC ACID| DIANEAL PD2| NPH INSULIN| CLONIDINE| FUROSEMIDE| OMEPRAZOLE| FOLIC ACID