BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2060268 · Received April 15, 2011

    Report

    Report Number
    1423500-2011-04592
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR LEAK WAS NOT CONFIRMED. THE CAUSE IS A LOOSE CONNECTION BETWEEN THE TRANSFER SET AND PATIENT CATHETER ADAPTER. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THAT THE TRANSFER SET FELL APART AND FLUID WAS LEAKING WHILE ON THE HOMECHOICE (HC) SYSTEM DURING DWELL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HOME PATIENT (HP) TO END THERAPY AND GET MEDICAL ATTENTION. THE TSR ASSISTED WITH ENDING THERAPY. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE NURSE, IT WAS REVEALED THAT THE TRANSFER SET HAD BEEN IN USE FOR A COUPLE OF MONTHS AND THE PATIENT HAD BEEN ON DIALYSIS FOR A YEAR AND A HALF. PER THE NURSE, THE LEAK WAS DUE TO A SEPARATION OF THE TRANSFER SET FROM THE CATHETER ADAPTER. THE CATHETER ADAPTER WAS PLASTIC AND MADE BY (B)(4). THE SEPARATION OCCURRED WHILE THE PATIENT WAS SLEEPING AND THE CATHETER WAS STORED AGAINST THE BODY USING TAPE. THERE WAS NO PATIENT INJURY AND PROPHYLACTIC ANTIBIOTICS WERE GIVEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR HOMECHOICE CYCLER