BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3823929 · Received May 21, 2014

    Report

    Report Number
    1416980-2014-16300
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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. THE GUIDE PROVIDES STEP-BY-STEP INSTRUCTIONS FOR PROPERLY DISCONNECTING DURING EMERGENCIES AND FOR RETURNING TO THERAPY AFTER THE EMERGENCY DISCONNECT PROCEDURE. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR AN UNRELATED ALARM ON THE HOMECHOICE (HC) MACHINE, IT WAS REPORTED THAT THE TRANSFER SET DISCONNECTED FROM THE TITANIUM ADAPTOR. THE STEP OF SETUP OR THERAPY DURING WHICH THIS OCCURRED WAS NOT SPECIFIED. THE PATIENT WAS HOSPITALIZED AFTER THIS EVENT. DURING FOLLOW-UP WITH THE PATIENT¿S REGISTERED NURSE (RN), THE RN STATED THAT THE PATIENT WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS BUT WAS NOT DIAGNOSED WITH PERITONITIS. THE RN STATED THAT THE DISCONNECTION OCCURRED BECAUSE THE PATIENT HAD PULLED THE TRANSFER SET OFF OF THE TITANIUM ADAPTOR AND THAT THERE WAS NO KNOWN DEFECT WITH EITHER PRODUCT. THE RN STATED THAT THE PATIENT¿S TRANSFER SET AND TITANIUM ADAPTOR WERE CHANGED IN THE HOSPITAL. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 FOR THIS PATIENT AND EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302898 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE AUTOMATED PD SET W/ CASSETTE| TITANIUM ADAPTOR| HOMECHOICE