BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3113656 · Received May 15, 2013

    Report

    Report Number
    1416980-2013-12371
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 28, 2013
    Report Date
    April 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN "THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE", WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. USERS ARE INSTRUCTED TO CHECK ALL DISPOSABLE SET CONNECTIONS FOR A SECURE FIT BEFORE BEGINNING PERITONEAL DIALYSIS THERAPY. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED. 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. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING AN ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 3 OF 4. PER THE HOME PATIENT (HP), THE TRANSFER SET BECAME UNDONE AND DRAINED OUT. PER THE HP, HE RECONNECTED. THE HP WOULD END THERAPY. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE RECEIVED A CALL FROM THE HOME PATIENT'S CAREGIVER AND HE SAID THAT HIS FATHER HAD NOT MADE A COMPLETE CONNECTION BETWEEN THE TRANSFER SET AND THE CASSETTE AND WHEN HE GOT UP IT CAME UNDONE. HE SAID SOLUTION CAME OUT OF THE TRANSFER SET. HE SAID THERE WAS NOTHING WRONG WITH THE SUPPLIES, IT WAS HIS FATHER'S FAULT THAT THE TRANSFER SET CAME UNDONE FROM THE PATIENT LINE. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215519 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR HOME CHOICE