BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1880701 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04862
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A DAMAGED SET IS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE ROOT CAUSE WAS DETERMINED TO BE ANIMAL DAMAGE FROM THE INFORMATION PROVIDED IN THE COMPLAINT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. 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'S TECHNICAL SERVICE CENTER REPORTING THAT A CAT BIT HER DRAIN LINE DURING DRAIN 3 OF 4 ON THE HOMECHOICE (HC) MACHINE. THE HOME PATIENT (HP) STATED THAT NO ALARMS WENT OFF AFTER CAT BIT DRAIN LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY EARLY, ADVISED TO DISCONNECT FROM THE HC MACHINE AND TO CONTACT NURSE ABOUT MISSED THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    DURING A FOLLOW UP WITH THE NURSE REGARDING THE CAT CHEWING THE LINE, IT WAS CONFIRMED THAT THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. PER NURSE, HOME PATIENT (HP) KNOWS NOT TO HAVE THE CAT AROUND WHEN PERFORMING THERAPY. THE NURSE ADDED THAT THE HP EXPLAINED TO HER THAT SHE HAD BEEN TO THE BATHROOM WHERE THE CAT SNUCK IN AND CHEWED THE LINE. THE NURSE VERIFIED THAT SHE HAD DISCUSSED THE PROPER PROCEDURES WITH THE HP. PER NURSE, HP IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. 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 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR