BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2023742 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03387
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 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.

    Description of Event or Problem · 1

    THIS IS A CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(6) OF PERITONITIS WITH CULTURE POSITIVE FOR STREPTOCOCCUS BOVIS GROUP +2 AND LINING IS SCARRED IN A MALE (AGE NOT REPORTED) COINCIDENT WITH DIANEAL PD4 AMBUFLEX (DIANEAL PD4 SYS II W/ 1.5%, 2.5%, AND 4.25%), EXTRANEAL VIAFLEX (EXTRANEAL SYS II 7.5%), AND NUTRINEAL PD4, UNKNOWN BAG, (NUTRINEAL SYS II 1.1%) THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DIANEAL PD4 SYS II W/ 1.5%, 2.5%, AND 4.25%) (8L), EXTRANEAL VIAFLEX (EXTRANEAL SYS II 7.5%) (2.5L), AND NUTRINEAL PD4, UNKNOWN BAG, (NUTRINEAL SYS II 1.1%) (2.5L) (FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT'S CAREGIVER CONTACTED BAXTER TECHNICAL SERVICES (BTS) REGARDING A LEAK THAT OCCURRED WHILE THE PATIENT WAS ON THE HOMECHOICE (HC) DEVICE. THE CAREGIVER STATED THAT THE PATIENT HAD LOOSENED THE TRANSFER SET AND THE CATHETER LEAKED OUT A LOT OF SOLUTION. THE BTS REPRESENTATIVE ADVISED THE CAREGIVER TO START OVER WITH NEW SUPPLIES. DURING THE CALL, THE CAREGIVER STATED THAT THE PATIENT HAD AN INFECTION AND WAS ON ANTIBIOTIC THERAPY. UPON FOLLOW UP ON (B)(6) 2011, THE PATIENT'S NURSE CLARIFIED THAT THE INFECTION WAS PERITONITIS. THE NURSE STATED THAT THE PATIENT WAS INITIALLY TREATED WITH REMEDIAL THERAPY OF CIPROFLOXACIN (DOSE, FREQUENCY, AND ROUTE NOT REPORTED). ON (B)(6) 2011, REMEDIAL THERAPY WITH CIPROFLOXACIN WAS STOPPED. THE PATIENT BEGAN REMEDIAL THERAPY WITH VANCOMYCIN (ORDERED (B)(6) 2011): 2G, IP, EVERY 5 DAYS, TIMES 2 DOSES. THE NURSE STATED THE CAUSE OF THE PERITONITIS WAS "DUE TO AN ERROR ON THE PATIENT'S SIDE, PROBABLE TOUCH CONTAMINATION." THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS, BUT THE NURSE STATED THAT SHE CONSIDERED THIS EVENT SERIOUS BECAUSE THE LINING IS SCARRED AND IT IS LIMITING THE PATIENT'S LIFE, IF THEY CONTINUALLY EXPERIENCE PERITONITIS. ON AN UNREPORTED DATE IN 2011, THE EVENT OF PERITONITIS RESOLVED. IT WAS NOT REPORTED WHETHER THE EVENT OF LINING IS SCARRED RESOLVED. DIANEAL PD4 AMBUFLEX, EXTRANEAL VIAFLEX AND NUTRINEAL PD4 THERAPIES WERE ONGOING. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE STATED THAT THE PERITONITIS WITH CULTURE POSITIVE FOR STREPTOCOCCUS BOVIS GROUP +2 WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX, EXTRANEAL VIAFLEX AND NUTRINEAL PD4 THERAPIES AND DID NOT PROVIDE A STATEMENT OF CAUSALITY FOR THE EVENT OF LINING IS SCARRED.

    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 Required Intervention NUTRINEAL PD4 1.1%| DIANEAL PD4 AMBUFLEX 1.5%, 2.5%, AND 4.25%| EXTRANEAL VIAFLEX 7.5%