BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1901308 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05878
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 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). 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 A LEAK 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 HOME PATIENT (HP)'S CAREGIVER (CG) CONTACTED (B)(4) REPORTING THAT THE HP SPRUNG A LEAK IN HIS CATHETER AND REQUESTED ASSISTANCE TO GET THE CASSETTE OUT OF THE HOMECHOICE (HC) DOOR DURING USE. THE HP HAD TO DISCONNECT FROM THE HC MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG BY ENDING THERAPY ON THE HC MACHINE AND RETRIEVING THE CASSETTE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. DURING A FOLLOW UP WITH THE NURSE, THE NURSE STATED THAT THE HP NOTICED THE TRANSFER SET HAD TOTALLY SEPARATED FROM THE CATHETER AND FOUND THE TRANSFER SET ON THE BED. THE NURSE STATED THAT THEY GAVE THE HP (B)(6) AND THE HP DID NOT HAVE ANY INFECTIONS. DURING FURTHER FOLLOW UP WITH THE NURSE, THE NURSE STATED THAT SHE SPOKE WITH THE HP AND THE ON-CALL NURSE, AND REPORTED THAT THE SEPARATION OCCURRED BETWEEN THE TRANSFER SET AND THE PLASTIC CATHETER ADAPTER. THE NURSE WAS NOT SURE OF THE EXACT CAUSE OF THE SEPARATION, HOWEVER SHE SUGGESTED THAT IT MIGHT HAVE BEEN LOOSE, AND THAT'S THE REASON WHY SHE ADVISES THE PATIENT TO VERIFY THE CONNECTION IS TIGHT PRIOR TO THERAPY. THE NURSE CONFIRMED THAT THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. PER NURSE, HP IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. 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