BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L5C4531 INTEGRATED APD SET W/CASSETTE 3 PRONG

    MDR report key: 1981944 · Received February 8, 2011

    Report

    Report Number
    1423500-2011-01665
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LEAK WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. THE ROOT CAUSE WAS NOT DETERMINED. 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 NURSE (RN) CONTACTED CORPORATE PRODUCT SURVEILLANCE (CPS) TO REPORT A LEAK IN THE CASSETTE DURING PATIENT USE. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. A FOLLOW UP WAS DONE VIA PHONE. THE HOME PATIENT STATED THAT AFTER STARTING OVER WITH NEW SUPPLIES, NO FURTHER ISSUES WERE FOUND. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L5C4531 INTEGRATED APD SET W/CASSETTE 3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10K14056

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR