BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1971393 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01076
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 3, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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 CANNOT BE DETERMINED AT THIS TIME. A 510(K) NUMBER WILL NOT BE PROVIDED 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 SOLICITED REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONITIS, SLIGHTLY CLOUDY EFFLUENT, AND LATENT ABDOMINAL PAIN IN AN APPROXIMATELY (B)(6) MALE PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX AND PHYSIONEAL, THERAPIES. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX ; 2000 ML EVERY DAY AND PHYSIONEAL; 2000 ML THREE TIMES PER DAY INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (CAPD) FOR GLOMERULAR NEPHROPATHY. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED SLIGHTLY CLOUDY EFFLUENT AND LATENT ABDOMINAL PAIN AND DEVELOPED PERITONITIS. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH CEFAZOLIN NATRIUM 1 GM IP AND GENTAMICINSULFAT 40 MG IP FOR PERITONITIS. ON (B)(6) 2011, TREATMENT WITH CEFAZOLIN NATRIUM AND GENTAMICINSULFAT WAS DISCONTINUED. THE PATIENT WAS RECOVERING FROM THE EVENTS OF SLIGHTLY CLOUDY EFFLUENT AND LATENT ABDOMINAL PAIN. ON AN UNREPORTED DATE, EXTRANEAL THERAPY WAS WITHDRAWN AS A RESULT OF THE EVENTS. PHYSIONEAL THERAPY WAS ONGOING AT THE SAME DOSE. THE PHYSICIAN BELIEVED THE EVENTS OF SLIGHTLY CLOUDY EFFLUENT AND LATENT ABDOMINAL PAIN WERE POSSIBLY RELATED TO EXTRANEAL. THE PHYSICIAN DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF PERITONITIS, NOR DID THE PHYSICIAN PROVIDE AN OPINION OF CAUSALITY FOR ANY OF THE EVENTS IN RELATION TO PHYSIONEAL THERAPY.

    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 49 Required Intervention ARANESP WITH ANS| CARMEN| NOVALGIN (METAMIZOLE)| CACLIUMACETAT NEFRO (CALCIUM ACETATE)| CALCITRIOL GRY| TORASEMID AL| APROVEL| MAGNESIUM - RATIOPHARM| FOSRENOL| OMEPRAZOL AL| DREISAFER| PREVASTATIN