BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2983278 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04936
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 12, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT REQUESTED AS THIS EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. 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. THIS COMPLAINT FOR A REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE IS CONFIRMED, BECAUSE IT WAS REPORTED THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE, WHICH LED TO PERITONITIS; HOWEVER, THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED, SINCE IT IS UNCERTAIN WHY THE PATIENT HAD A BREACH IN ASEPTIC TECHNIQUE. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED

    Description of Event or Problem · 1

    THIS IS A REPORT OF A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY, WHICH CAUSED PERITONITIS. IT WAS REPORTED THAT A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR A LOW PLATELET COUNT. TREATMENT RENDERED AND THE CAUSE OF LOW PLATELET COUNT WAS NOT REPORTED. THE PATIENT RECOVERED FROM THIS EVENT. THE PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE, DESCRIBED AS THE PATIENT MADE THE MISTAKE OF TOUCH CONTAMINATION, WHICH LED TO PERITONITIS MANIFESTED BY CLOUDY EFFLUENT. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. TWO SURGERIES WERE PERFORMED WHILE THE PATIENT WAS HOSPITALIZED. THE FIRST WAS TO REMOVE THE CATHETER, DUE TO THE PERITONITIS, AND THE SECOND WAS PERFORMED EIGHT DAYS LATER FOR DIVERTICULITIS (ONSET DATE NOT REPORTED). THE PATIENT IS RECOVERING FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88580 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R HOMECHOICE| DIANEAL PD4 AMBUFLEX