BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1843102 · Received September 23, 2010

    Report

    Report Number
    1423500-2010-03669
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT BEING RETURNED FOR EVALUATION, THEREFORE, BAXTER CANNOT DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE, THEREFORE, BAXTER COULD NOT DETERMINE ROOT CAUSE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. THE LABELING REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IDENTIFIED IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING A CALL TO BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A LOW DRAIN VOLUME ALARM ON THE HOMECHOICE (HC) MACHINE, THE HOME PATIENT (HP) STATED THAT HE LEAKED OUT A LOT OF FLUID THIS MORNING BECAUSE HE FORGOT TO CLOSE HIS TRANSFER SET. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT IS WHY THE ALARM OCCURRED. THE TSR ASSISTED WITH BYPASS TO FILL 1. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S NURSE ON (B)(4) 2010. ACCORDING TO THE NURSE, THE PATIENT HAS NOT REPORTED ANY ISSUES TO HER. THE PATIENT HAS BEEN SEEN SINCE THIS EVENT AND THE TRANSFER SET IS FUNCTIONING PROPERLY. THE PATIENT WAS ABLE TO RESUME THERAPY WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR