BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1940082 · Received December 29, 2010

    Report

    Report Number
    1423500-2010-07344
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    November 26, 2010
    Report Date
    December 5, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS REPORTED REGARDING A PIN HOLE LEAK FOUND IN THE PATIENT LINE DURING INITIAL DRAIN. THIS COMPLAINT WAS NOT CONFIRMED AND NO ROOT CAUSE WAS DETERMINED BECAUSE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER 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) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A PIN HOLE LEAK FOUND IN THE PATIENT LINE, THIS OCCURRED ON THE HOME CHOICE (HC) UNIT DURING INITIAL DRAIN. THE HP STATED, HE HAD ALREADY CLOSED THE TRANSFER SET. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR ADVISED THE HP TO CALL THE NURSE ABOUT THE LEAK. PRODUCT SURVEILLANCE FOLLOWED UP WITH THE NURSE (RN) VIA PHONE CALL. PER THE RN, SHE WAS AWARE OF THE PIN HOLE AND SHE STATED THAT THE HP DID NOT HAVE A FEVER AND HIS HEMOGLOBIN WAS ON THE RISE. THE RN STATED THERE WAS NO MEDICAL INTERVENTION. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE FOLLOWED UP WITH THE HP VIA PHONE CALL. PER THE HP, THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS H10J22101. THE HP STATED, HE HAD NOT HAD ANY PROBLEMS WITH THE CASSETTES PRIOR TO THIS. THE HP RESUMED THERAPY USING NEW SUPPLIES WITHOUT ANY PROBLEMS. THE HP STATED, HE CONTACTED HIS PD RN AND THERE WAS NO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10J22101

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR PD CYCLER