BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1994064 · Received February 16, 2011

    Report

    Report Number
    1423500-2011-02061
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    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 SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF AIR IN TUBING IN MULTIPLE LINES. PER THE COMPLAINT INFORMATION, THE PATIENT INADVERTENTLY PUT A SMALL HOLE IN THE CONNECTED SOLUTION BAG WHEN PUTTING A CLAMP ON. THE PATIENT STATED, SHE DID NOT HAVE ANY MORE SOLUTION BAGS WITH HER, SO SHE STERILIZED THE BAG AND PUT MEDICAL TAPE OVER THE HOLE. THE PATIENT CONTINUED THERAPY USING THESE SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE AIR IN TUBING IS USER ERROR. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR 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 HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REQUESTING TO START OVER WITH NEW SUPPLIES OF THE HOME CHOICE (HC). THE HP STATED SHE WAS IN THE INITIAL DRAIN CYCLE WITH A DRAIN VOLUME (DV)=44ML. THE HP STATED THE LINES WERE FULL OF HUGE AIR BUBBLES. THE HP STATED SHE WANTED TO START OVER WITH ALL NEW SUPPLIES. THE TECHNICAL SERVICES REPRESENTATIVE (TSR) INSTRUCTED THE HP TO CYCLE THE POWER OFF/ON AND END THE THERAPY TO START OVER WITH ALL NEW SUPPLIES. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE HP WHO STATED SHE WAS OUT OF TOWN WITH LIMITED SUPPLIES THE NIGHT OF THIS INCIDENT. THE HP CONFIRMED SHE COMPROMISED THE CASSETTE. THE HP STATED SHE CHANGED OUT THE CASSETTE AND WHILE DOING THIS, PUT A CLAMP ON THE SOLUTION BAG LINE AND GOT TOO CLOSE TO THE PORT CAUSING A SMALL HOLE IN THE BAG. THE HP STATED SHE DID NOT HAVE ANY MORE SOLUTION BAGS WITH HER SO SHE STERILIZED THE BAG AND PUT MEDICAL TAPE OVER THE HOLE. THE HP STATED SHE CONTINUED THERAPY USING THESE SUPPLIES. THE HP STATED THE SUPPLIES WERE DISCARDED AND THE LOT NUMBER WAS NOT KNOWN. THE HP STATED SHE HAS CONTINUED THERAPY WITHOUT ANY FURTHER PROBLEMS. PRODUCT SURVEILLANCE ADVISED THE HP TO CONTACTED HER PD RN TO ADVISE OF THIS REPORT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HOMECHOICE APD CYCLER