BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3090692 · Received May 2, 2013

    Report

    Report Number
    1416980-2013-11171
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 21, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED IN THE INCIDENT WAS UNKNOWN. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. THIS COMPLAINT FOR USE ERROR - REUSE OF SINGLE-USE SUPPLIES IS CONFIRMED BECAUSE IT WAS REPORTED IN THE EVENT DESCRIPTION THAT THE USER REUSED SAME SUPPLY BAG AFTER STARTING WITH NEW CASSETTE. THE ASSIGNABLE CAUSE CODE WAS UNDETERMINED BECAUSE EVEN THOUGH THE USE ERROR WAS IDENTIFIED, IT IS UNDETERMINED WHY THE DISPOSABLE WAS REUSED. THE PROBLEM WAS CONFIRMED FOR THIS USE ERROR - REUSE OF SINGLE USE SUPPLIES COMPLAINT, BECAUSE THERE WAS A DEFINED USE ERROR. LABELING REVIEW FOUND THAT ALL PRINTED POUCHES FOR DISPOSABLE PRODUCTS INTENDED FOR SINGLE USE ARE LABELED WITH "THIS DEVICE IS INTENDED FOR SINGLE USE ONLY."

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A CHECK SUPPLY LINE ALARM ((B)(4)), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING LAST FILL. PER THE REGISTERED NURSE (RN) NO SOLUTION IN ANY OF THE BAGS, THE RN DISCONNECTED AND RECONNECTED A BAG ON THE HEATER (THIS COMPLAINT). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED, ASSISTED TO END THERAPY, THE RN TO FOLLOW UP WITH MANUAL EXCHANGE. THE TSR REVIEWED PROGRAM, CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD), THE TOTAL VOLUME EQUALED 12000ML, THE FILL VOLUME (FV) WAS EQUAL TO 2500ML, THE LAST FILL VOLUME (LFV) WAS EQUAL TO WAS 2000ML, DEXTROSE WAS SET TO SAME, AND THE NUMBER CYCLES WAS SET TO 4. THE RN CONNECTED 2, 6L BAGS. THE TSR EXPLAINED THE POSSIBLE CAUSES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191998 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE