BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1882048 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04886
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 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). 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). THE LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. 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 A CONNECTION ISSUE WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. A ROOT CAUSE WAS NOT IDENTIFIED. 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 CATHETER FELL APART AND WANTED ASSISTANCE TO END THERAPY DURING DWELL 1 ON THE HOMECHOICE (HC) MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CAREGIVER (CG) IN ENDING THERAPY. THE CG WOULD CONTACT THE PERITONEAL DIALYSIS NURSE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    DURING A FOLLOW UP WITH THE NURSE REGARDING THE CATHETER FALLING APART, IT WAS REVEALED THAT THE HOME PATIENT (HP) HAD ACTUALLY TRIPPED AND FALLEN DURING EXERCISE, AND THE TUBING WAS PULLED HARD. THE NURSE SUGGESTED THAT THIS EVENT MAY HAVE LOOSENED THE CONNECTION AT THE TITANIUM ADAPTER. THE NURSE WAS UNSURE IF THE SEPARATION OCCURRED BETWEEN THE TITANIUM ADAPTER AND THE CATHETER, OR THE TITANIUM ADAPTER AND THE TRANSFER SET. PER NURSE, THE TITANIUM ADAPTER AND THE TRANSFER SET WERE REPLACED. THE NURSE BELIEVED THE SEPARATION OCCURRED DUE TO THE FALL AND SUBSEQUENT "TRAUMA" TO THE TITANIUM ADAPTER CONNECTION. PER NURSE, HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE NURSE ADDED THAT THE HP WAS GIVEN PROPHYLACTIC ANTIBIOTICS. NO FURTHER INFORMATION WAS PROVIDED.

    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 13 YR