BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3013121 · Received March 20, 2013

    Report

    Report Number
    1416980-2013-06706
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 24, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - REUSE OF SINGLE-USE PRODUCT IS CONFIRMED, BECAUSE IT WAS REPORTED THAT THERE WAS A REUSE OF SINGLE USE PRODUCTS; HOWEVER, THE ASSIGNABLE CAUSE CODE COULD NOT BE DETERMINED, SINCE IT IS UNSURE WHY THE PATIENT HAD REUSED THE SINGLE USE PRODUCTS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A SAMPLE WAS NOT REQUESTED BECAUSE THE EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION AGAINST THE DEVICE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT (PT) IN INDIA HAD A BREAK ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS. ON AN UNREPORTED DATE, THE PT BEGAN TREATMENT WITH DIANEAL 1.5% ULTRABAG THERAPY (DOSE, AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PT HAD A BREAK IN ASEPTIC TECHNIQUE FURTHER DESCRIBED AS DID NOT CLEAN AREA BEFORE STARTING PD AND REUSED EQUIPMENT. SUBSEQUENTLY, THE PT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE, THE PT WAS HOSPITALIZED FOR THE PERITONITIS. THE CAUSE OF THE PERITONITIS WAS THE BREAK IN ASEPTIC TECHNIQUE. ON AN UNREPORTED DATE, THE PT WAS TREATED BY INJECTION (INJ) WITH VANCOTROY (IP, 2G STAT) AND GENTAMYCIN (IP, 20MG ONCE DAILY FOR 7DAYS). CONCOMITANT THERAPY WAS NOT REPORTED. THE OUTCOME OF THE PERITONITIS WAS UNKNOWN. IT WAS NOT REPORTED WHETHER THE PT WAS RE-TRAINED IN PROPER ASEPTIC PROCEDURES FOR PD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115963 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R DIANEAL 1.5% ULTRABAG