BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1914804 · Received December 4, 2010

    Report

    Report Number
    1423500-2010-06531
    Event Type
    Malfunction
    Date Received
    December 4, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LEAK 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. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR 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 CARE GIVER (CG) CONTACTED (B)(4) REGARDING THE HOME PATIENT (HP) WAKING UP TO FIND THE BED WET, THIS OCCURRED ON THE HOME CHOICE (HC) UNIT DURING DWELL 4. THE CG STATED SHE CAUGHT IT IN TIME, THERE WAS NO ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CG END THERAPY, CLOSE THE CLAMPS AND CAP OFF THE HP. THE TSR ADVISED THE CG TO CALL THE NURSE FOR FURTHER MEDICAL INSTRUCTIONS. THE WRITER FOLLOWED UP WITH THE NURSE. THE RN STATED THE HOME PATIENT (HP) HAS DISCONNECTED THE TRANSFER SET FROM THE PATIENT LINE IN THEIR SLEEP. THE HP WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS. THE HP HAS SINCE CONTINUED THERAPY WITH NO ISSUES AND NO ADVERSE EVENTS HAVE RESULTED AS A RESULT OF THIS ISSUE

    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 81 YR (B)(4) 1.5% LO/CAL 5L/5L DIANEAL (B)(4) EXTRANE