BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2981390 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04829
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE OF OCCURRENCE IS UNKNOWN; HOWEVER, THE PATIENT WAS DIAGNOSED WITH PERITONITIS THE WEEK OF (B)(6) 2013. THIS EVENT INVOLVED A USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION; THEREFORE, A SAMPLE WAS NOT REQUESTED. THIS REPORT OF A USE ERROR-BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS WAS CONFIRMED. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. 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 ROOT CAUSE FOR THE USE ERROR WAS UNDETERMINED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED WORSENING OF DIABETIC NEUROPATHY. IN (B)(6) 2013, THE PATIENT EXPERIENCED A BOWEL OBSTRUCTION AND LOW POTASSIUM. ON (B)(6) 2013, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND WAS HOSPITALIZED FOR CHRONIC CONSTIPATION (ONSET NOT REPORTED) AND BOWEL OBSTRUCTION ON THE SAME DAY. THE ABDOMINAL PAIN WAS CONSIDERED A MANIFESTATION OF THE BOWEL OBSTRUCTION. IN (B)(6) 2013, TREATMENT FOR THE CONSTIPATION AND BOWEL OBSTRUCTION INCLUDED ORAL MIRALAX AND ORAL GOLYTELY. IN (B)(6) 2013, TREATMENT FOR THE LOW POTASSIUM INCLUDED A POTASSIUM SUPPLEMENT. THE PATIENT WAS STILL HOSPITALIZED. THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS, BUT HAD RECOVERED FROM THE EVENTS OF BOWEL OBSTRUCTION AND LOW POTASSIUM. THE PATIENT HAD NOT RECOVERED FROM WORSENING DIABETIC NEUROPATHY AND CHRONIC CONSTIPATION.

    Description of Event or Problem · 1

    THIS IS A REPORT OF PERITONITIS CAUSED BY A BREACH IN ASEPTIC TECHNIQUE. PERITONEAL DIALYSIS (PD) THERAPY WAS ONGOING AND THE PATIENT WAS TREATED WITH VANCOMYCIN AND CEFTAZIDIME (INTRAPERITONEALLY, DOSE AND FREQUENCY UNKNOWN). THE PATIENT RECEIVED RETRAINING ON HOW TO PERFORM PD THERAPY USING PROPER ASEPTIC TECHNIQUE. THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84901 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention DIANEAL PD4 LOW CALCIUM ULTRABAG| HOMECHOICE, DIANEAL PD4 AMBUFLEX