BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 1963889 · Received January 19, 2011

    Report

    Report Number
    1423500-2011-00764
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 25, 2010
    Report Date
    December 25, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF THE PATIENT'S TRANSFER SET INCORRECTLY CLOSED WHEN TRYING TO BEGIN THERAPY WAS NOT CONFIRMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS USE ERROR WAS NOT DETERMINED. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. A BATCH REVIEW WILL NOT BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THERAPY RESUMED WITH ACTUAL PRODUCT. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REQUESTING ASSISTANCE WITH THERAPY ON THE HOMECHOICE MACHINE DURING FILL 1. THE HP STATED THAT HE DID NOT GET ON THE CYCLER EMPTY. THE HP STATED HE DOES A MANUAL FILL OF 2000 ML DURING THE DAY. THE HP FURTHER STATED HIS TRANSFER SET WAS CLOSED, SO HE OPENED IT AND STARTED THE FILL BUT WAS UNSURE IF HE WAS EMPTY. THE HP CONFIRMED HE WAS IN FILL 1 AND THE FILL VOLUME WAS 715 ML. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) ASSISTED THE HP WITH A MANUAL DRAIN AND EXPLAINED THAT THIS WOULD DRAIN HIM EMPTY. THE TSR FURTHER ADVISED THE MACHINE WOULD THEN SAY 'STOPPED FILL'. THE HP CONFIRMED HE WOULD PRESS GO TO RESUME THERAPY. THE HP FURTHER STATED HE WOULD MONITOR THE DRAIN VOLUME AND RESUME THERAPY WHEN DRAIN COMPLETED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR HOMECHOICE PRO