BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2222266 · Received August 24, 2011

    Report

    Report Number
    1423500-2011-11205
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 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 DEVICE HAD BEEN DISCARDED AND THE LOT NUMBER WAS UNKNOWN, A BATCH REVIEW COULD NOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN, THEREFORE A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED AIR ALARM. THE HOME PATIENT (HP) WAS CONNECTED. THE CAREGIVER (CG) SAID THERE WERE NO LEAKS. THE CG ALREADY CYCLED POWER AND WAS DISPOSING OF SUPPLIES WHEN SHE CALLED. THE TSR RECOMMENDED TO CALL REGISTERED NURSE (RN) ABOUT AIR ALARM. THE CG WOULD CALL THE RN REGARDING ALARM. THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED CAREGIVER (CG) ON (B)(4) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE CG REPORTED THAT THE ISSUE WAS RESOLVED, BUT SHE DID NOT KNOW THE CAUSE OF THE ALARM. PER CG, THERE WERE NO LOOSE CONNECTIONS, (UNINTENTIONAL) DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER CG, THE HOME PATIENT (HP) DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE CG STATED THAT THE HP IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE CG STATED THAT SHE HAD DISCARDED THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBERS. 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 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE