BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2042644 · Received April 6, 2011

    Report

    Report Number
    1423500-2011-04164
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THIS REPORT FOR A REPORT OF A DISCONNECTION OF THE HEATER LINE TUBING FROM THE CASSETTE WAS RETURNED FOR INVESTIGATION. SET WAS VISUALLY INSPECTED AND NOTED THAT THE HEATER LINE TUBING WAS SEPARATED FROM THE CASSETTE PORT. DURING VISUAL INSPECTION OF THE PORT AND TUBING, BOTH APPEARED TO HAVE SOLVENT. THE TUBING CONTAINED AN UNEVEN EDGE. THE REPORT WAS CONFIRMED IN THE LAB FOR CONNECTION ISSUE. A BATCH REVIEW WAS PERFORMED ON THE ASSOCIATED LOT (H09J06065) WITH NO ISSUES NOTED. PER THE RESULTS OF EVALUATION, THE COMPLAINT DOES NOT PROVIDE SUFFICIENT INFORMATION TO IDENTIFY ROOT CAUSE, THEREFORE THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. 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

    IT WAS REPORTED TO BAXTER (B)(4) THAT THERE WAS A DISCONNECT OF THE TUBING FROM THE CASSETTE; THE HEATER BAG TUBING WAS FOUND DISCONNECTED FROM THE CASSETTE. THIS OCCURRED BEFORE USE. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H09J06065

    Patients

    Seq Age Sex Outcome Treatment
    1