BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1970752 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-01034
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 6, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. 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 WILL NOT 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 REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF PERITONEAL CLOUDY EFFLUENT AND ABDOMINAL PAIN IN A PATIENT COINCIDENT WITH PHYSIONEAL AND NUTRINEAL PD4 THERAPIES INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2010, THE PATIENT EXPERIENCED CLOUDY EFFLUENT AND ABDOMINAL PAIN. THE PATIENT WAS WITHOUT A FEVER. ON AN UNREPORTED DATE IN (B)(6) 2010, THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (1.5G, FREQUENCY NOT REPORTED, IP) FOR 14 DAYS AND GENTAMYCIN (DOSE AND FREQUENCY NOT REPORTED, IP). ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH CIPROFLOXACIN (500MG, TWICE DAILY, ORALLY). ON THE SAME DAY, REMEDIAL THERAPY WITH GENTAMYCIN ENDED. ON (B)(6) 2011, THE PATIENT ENDED REMEDIAL THERAPY WITH CIPROFLOXACIN. ON (B)(6) 2011, THE PATIENT ENDED REMEDIAL THERAPY WITH VANCOMYCIN. ON AN UNREPORTED DATE, THE PATIENT IMPROVED WITH THE DISCONTINUATION OF NUTRINEAL PD4. THE NURSE STATED THAT THE CAUSE OF THE CLOUDY EFFLUENT WAS QUESTIONABLE NUTRINEAL CONTAMINATION. ON AN UNREPORTED DATE, THE PATIENT WAS RECOVERED WITH SEQUELAE AFTER EXPOSURE TO IP ANTIBIOTICS. PHYSIONEAL USE WAS ONGOING. THE NURSE STATED THAT THE CLOUDY EFFLUENT AND ABDOMINAL PAIN WERE RELATED TO THE NUTRINEAL PD4 UNKNOWN BAG AND WERE UNRELATED TO THE PHYSIONEAL, UNSPECIFIED PRODUCT.

    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 59 YR Hospitalization| R NUTRINEAL PD 4| PHYSIONEAL