BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1893507 · Received November 8, 2010

    Report

    Report Number
    1423500-2010-05473
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 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). THE ISSUE WAS RESOLVED OVER THE PHONE. THIS WAS AN INCIDENT INVOLVING A USER ERROR DURING THERAPY AND THERE WAS NO ALLEGATION AGAINST THE BAXTER PRODUCT; THEREFORE THE SAMPLE WILL NOT BE REQUESTED FOR EVALUATION. 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 SAMPLE EVALUATION WAS NOT PERFORMED 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 HE PULLED THE TRANSFER SET OFF OF HIMSELF WHEN HE STRETCHED IT TOO FAR TRYING TO GRAB SOMETHING IN THE KITCHEN DURING DWELL 3 OF 3 ON THE HOME CHOICE (HC) MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO END THERAPY AND THE HP WOULD CONTACT THE NURSE. DURING A FOLLOW UP WITH THE HP'S WIFE REGARDING THE SEPARATION, THE WIFE EXPLAINED THAT THE HP HAD BEEN STRETCHING TOO FAR BACK TO REACH FOR A COFFEE POT THAT WAS ON ANOTHER TABLE, AND PULLED HARD ON THE TUBING. PER WIFE, THE DISCONNECTION OCCURRED BETWEEN THE TRANSFER SET AND THE PATIENT LINE. THE WIFE CONFIRMED THAT THERE WERE NO LOOSE CONNECTIONS OR DEFECTS ON THE PRODUCTS. THE WIFE STATED THAT SHE HAS NOW MOVED THE COFFEE TABLE CLOSER TO THE HP, SO HE DOES NOT HAVE TO LEAN TOO FAR. THE WIFE STATED THAT THE TRANSFER SET WAS REPLACED, AND CONFIRMED THAT THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. PER WIFE, HP IS DOING FINE AND CONTINUING THERAPY. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. 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 70 YR