BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1872846 · Received October 18, 2010

    Report

    Report Number
    1423500-2010-04554
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    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). THIS COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A RELATED COMPLAINT, THE CAREGIVER (CG) STATED THAT THE HOME PATIENT (HP) HAD A NEW TRANSFER SET PUT ON AND THE NEW TRANSFER SET IS LOOSE AND DOES NOT STAY ON. THE CG STATED THE SITE WAS NOT WET BUT THE TRANSFER SET WAS NOT RIGHT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO CONTACT THE PERITONEAL DIALYSIS NURSE. ON (B)(6) 2010 PRODUCT SURVEILLANCE SPOKE WITH THE CG WHO STATED THE TRANSFER SET WAS REPLACED AND SHE HAS HAD NO FURTHER ISSUES WITH HER MOM'S THERAPY. THE CG STATED THE TRANSFER SET WAS IN USE FOR ABOUT 5 DAYS; THE 4TH AND 5TH DAY SHE EXPERIENCED AIR IN LINE ALARMS DURING THERAPY. THE CG STATED HER MOM WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS AND THE TRANSFER SET AND PLASTIC ADAPTER WERE BOTH REPLACED AT THE HOSPITAL. THE CG STATED THE TRANSFER SET NEVER DISCONNECTED; HOWEVER, THE TRANSFER SET HAD TO HAVE BEEN LOOSE SOMEWHERE SINCE AIR ENTERED SET UP DURING THERAPY. THE CG STATED SHE DID NOT SEE ANY VISIBLE DAMAGE TO THE PRODUCT AND WAS NOT AWARE OF ANYTHING THAT WOULD HAVE CAUSED THE CONNECTION TO BE LOOSE. THE CG CONFIRMED THERE WAS NO LEAKAGE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR