BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2973546 · Received February 22, 2013

    Report

    Report Number
    1416980-2013-04418
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 20, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER WAS UNKNOWN; THEREFORE A SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED. THE REPORTED ISSUE WAS CONFIRMED TO BE CAUSED BY USE ERROR AS THERE WAS A BREAK IN ASEPTIC TECHNIQUE BY THE USER, DESCRIBED AS MADE MISTAKE, TOUCH CONTAMINATION AND DID NOT WEAR A MASK. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE FURTHER DESCRIBED AS THE PATIENT MADE MISTAKE, TOUCH CONTAMINATION AND DID NOT WEAR A MASK WHILE USING UNKNOWN BAXTER PERITONEAL DIALYSIS (PD) DISPOSABLES DURING PD THERAPY FURTHER WHICH CAUSED PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS FOR THE ENTIRE COURSE OF THE HOSPITAL STAY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, BUT HAD NOT YET BEEN SEEN IN THE PD CLINIC SINCE THE EVENT; THEREFORE OUTCOME OF PERITONITIS WAS UNKNOWN AND RETRAINING ON PROPER ASEPTIC TECHNIQUE HAD NOT YET BEEN PERFORMED. ACCORDING TO THE NURSE, AS PART OF THE CLINIC'S PROTOCOL, ALL PATIENTS RECEIVE RETRAINING ON ASEPTIC TECHNIQUE FOLLOWING ANY PERITONITIS EVENT AND THE PATIENT WILL BE RETRAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78300 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R HOMECHOICE| DIANEAL PD4 AMBUFLEX