BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1243110 · Received November 21, 2008

    Report

    Report Number
    1423500-2008-00931
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    November 19, 2008
    Report Date
    November 19, 2008
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K842885A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE PT'S NURSE, THE SAMPLE WAS DISCARDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE IN DWELL 4 OF 4. PER THE INITIAL REPORT, THE HOME PT (HP) STATED THAT THEIR TRANSFER SET WAS LEAKING AND HAD TO DISCONNECT FROM THE HOMECHOICE MACHINE AND END THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY AND RETRIEVE THE CASSETTE FROM THE HC MACHINE. THE HP WOULD GO SEE THE DOCTOR THAT DAY. CORPORATE PRODUCT SURVEILLANCE (CPS) SPOKE TO THE HOME PT'S PERITONEAL DIALYSIS (PD) NURSE IN 2008. PER THE CONVERSATION WITH THE NURSE, THE TRANSFER SET BECAME DISCONNECTED FROM THE PT'S CATHETER AND THAT IS THE REASON IT WAS LEAKING. THE TRANSFER SET WAS DISCARDED AT THE TIME IT WAS REPLACED ON THE HOME PT. THE NURSE HAD NO INPUT AS TO HOW THE TRANSFERRED SET BECAME DISCONNECTED. THE NURSE HAD NO INFORMATION REGARDING THE LOT NUMBER OF THE TRANSFER SET INVOLVED. THERE WAS NO PT INJURY AND THE PT HAS CONTINUED THERAPY WITHOUT FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP 78KDJ KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1