BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2100941 · Received May 24, 2011

    Report

    Report Number
    1423500-2011-06418
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 30, 2011
    Report Date
    April 30, 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). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. 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). UPON FURTHER REVIEW OF THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, IT WAS DETERMINED THAT THIS EVENT INVOLVED A DRUG PRODUCT AND NOT A DEVICE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DRAIN 5 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP RECYCLE THE POWER TO CLEAR THE ALARM AND EXPLAINED THE ALARM. THE HP WOULD DISCARD THE SUPPLIES AND FINISH WITH MANUALS. THE HP STATED THE CLAMP ON THE SUPPLY LINE WAS CRIMPED AND THE BAG WAS LEAKING. THE HP WOULD CONTACT THE NURSE REGARDING THE ALARM AND BEING CONNECTED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING FOLLOW UP BY BAXTER, THE HOME PATIENT (HP) STATED THAT THE ISSUE WAS RESOLVED. THE HP VERIFIED THAT THERE WERE NO OTHER LOOSE CONNECTIONS OR DISCONNECTIONS. PER HP, THEY DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE HP STATED THAT THEY WERE DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR HOMECHOICE