BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1943347 · Received January 1, 2011

    Report

    Report Number
    1423500-2010-07518
    Event Type
    Malfunction
    Date Received
    January 1, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 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). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF AIR IN THE PATIENT LINE. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE AIR IN TUBING IS USE ERROR. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. 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 CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING THE HOME CHOICE (HC) PROBLEM OF NEEDING TO END THERAPY IN INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) AS THE HC DETECTED AIR IN THE HP LINE DURING INITIAL DRAIN AND THE WANTED TO END THERAPY AND START OVER WITH NEW DISPOSABLES. THE TSR ASSISTED THE HP TO END THERAPY. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. PRODUCT SURVEILLANCE CONTACTED THE HP REGARDING THE AIR IN LINE. THE HP EXPLAINED THAT IT WAS HER FAULT, AS SHE HAD NOT PAID ATTENTION TO MAKE SURE THE LEVEL OF THE FLUID WAS TO THE TOP AT THE END OF PRIME, FURTHERMORE, SHE REALIZED THAT SHE HAD ALSO FORGOTTEN TO OPEN ONE OF THE CLAMPS. THE HP SUGGESTED THAT'S HOW THE AIR MUST HAVE COME IN TO THE LINE. PER HP, THE ISSUE WAS RESOLVED AND SHE RESUMED THERAPY USING NEW SUPPLIES. THE HP STATED THAT SHE IS AWARE OF THE PROPER PROCEDURE, AND THAT IT WAS HER MISTAKE AS SHE WAS JUST NOT PAYING ATTENTION THAT DAY. PER HP, SHE HAS HAD NO PROBLEMS WITH THERAPY SINCE. THE HP STATED THAT SHE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. 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 HOMECHOICE CYCLER