BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1880675 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04858
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: PER THE CUSTOMER THE SAMPLE WAS DISCARDED, THEREFORE, NO EVALUATION COULD BE PERFORMED. THIS COMPLAINT FOR PROBLEM CODE DAMAGED IS NOT CONFIRMED DUE TO LACK OF SAMPLE. A CUSTOMER REPORTED THAT A CASSETTE HAD A HOLE IN THE TUBING WHERE IT CONNECTS. DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE TO THE NURSE ON (B)(6) 2010 REGARDING HOLE IN CASSETTE, THE NURSE STATED THAT SHE WAS AWARE OF THE HOLE IN CASSETTE FOUND BY THE HOME PATIENT. ROOT CAUSE WAS UNDETERMINED DUE TO LACK OF SAMPLE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THAT A CASSETTE HAD A HOLE IN THE TUBING WHERE IT CONNECTS. DURING A FOLLOW UP WITH THE NURSE REGARDING HOLE IN CASSETTE, THE NURSE STATED THAT SHE WAS AWARE OF THE HOLE IN CASSETTE FOUND BY THE HOME PATIENT (HP). THE NURSE CONFIRMED THAT HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. PER NURSE, HP WAS SEEN IN THE CLINIC LAST WEEK, AND WAS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. 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 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10F10038

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR