BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1963040 · Received January 18, 2011

    Report

    Report Number
    1423500-2011-00729
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 25, 2010
    Report Date
    December 25, 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 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 REPORT FOR A SYSTEM ERROR (SE) 2240 ALARM WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG FELL AND DISCONNECTED. THE CAREGIVER (CG) STATED A BAG FELL OFF THE STAND AND BECAME DISCONNECTED; ADDING THAT IT MAY HAVE BEEN BUMPED CAUSING IT TO FALL. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A CAREGIVER (CG) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DWELL 4 OF 4. THE CG STATED A BAG FELL OFF THE STAND AND BECAME DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND ADVISED THE CG TO CYCLE POWER TO CLEAR ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ON (B)(6) 2010, PRODUCT SURVEILLANCE CONTACTED THE CG WHO STATED THE PATIENT WAS ASLEEP AT THE TIME THE BAG FELL BUT HER NIECE WAS OVER AND STATED SHE MAY HAVE BUMPED THE BAG ON THE WAY TO THE BATHROOM CAUSING IT TO FALL. THE CG CONFIRMED THE HP HAS RESUMED THERAPY WITHOUT FURTHER ISSUE.

    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 24 YR HOMECHOICE APD SYSTEM (B)(4) REFURBISHED