BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER FOR PERITONEAL DIAL CATH

    MDR report key: 1875362 · Received October 19, 2010

    Report

    Report Number
    1423500-2010-04643
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    July 1, 2009
    Report Date
    September 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AT A BAXTER PATIENT ADVISORY COUNCIL TEAM (PACT) MEETING ON 21 SEP 2010, A PATIENT REPORTED THAT THE TRANSFER SET HAD BECOME DISCONNECTED FROM HIS CATHETER. UPON FOLLOW-UP WITH THE PERITONEAL DIALYSIS (PD) REGISTERED NURSE (RN) ON 19 OCT 2010, THE PD RN STATED THE INCIDENT OCCURRED IN (B)(6) 2009. THE PATIENT USUALLY LET THE TRANSFER SET HANG LOOSE AND HAD GOTTEN THE CATHETER/TRANSFER SET CAUGHT IN THE RECLINER. THE HP STOOD UP FROM THE RECLINER AND THE CATHETER ADAPTER SEPARATED FROM THE CATHETER. THE HP WAS IN THE HOSPITAL FOR ISSUES UNRELATED TO PERITONEAL DIALYSIS (PD), WHERE THE PATIENT RECEIVED A NEW CATHETER ADAPTER AND TRANSFER SET AND WAS GIVEN PROPHYLACTIC ANTIBIOTICS (ANCEF). THE TRANSFER SET AND CATHETER ADAPTER WERE DISCARDED. THE CATHETER ADAPTER HAD NO VISIBLE DAMAGE. THE PATIENT KNOWS THE PROPER PROCEDURES. THE TRANSFER SET HAD BEEN IN USE SINCE (B)(6) 2009 AND THE PATIENT HAD BEEN ON PD FOR APPROXIMATELY 5 YEARS. THE PATIENT PERFORMED AUTOMATED PD. THE CATHETER ADAPTER WAS A TITANIUM ADAPTER MADE BY BAXTER, PRODUCT CODE AND LOT NUMBER UNKNOWN. THE CATHETER WAS MADE BY QUENTIN, PRODUCT CODE AND LOT NUMBER UNKNOWN. THE CATHETER WAS SWITCHED OUT A MONTH AFTER THE INCIDENT AND THE CATHETER WAS DISCARDED AT THAT POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING TITANIUM ADAPTER FOR PERITONEAL DIAL CATH SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR