BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2212660 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10743
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 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 A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS CONFIRMED AND CAUSE WAS DUE TO USE ERROR. THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION REPORTED BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) REGARDING A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HOME PATIENT (HP) STATED THAT THE UNUSED LINE CLAMP WAS OPEN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM TO THE HOME PATIENT (HP). THE HP CYCLED POWER TO DISPLAY PRESS GO TO START. THE HP WOULD RESTART WITH NEW SUPPLIES. THE HC IS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE HOME PATIENT (HP) STATED THAT THE ISSUE WAS RESOLVED BY STARTING OVER WITH NEW SUPPLIES. THE HP CONFIRMED THAT HE DID LEAVE A CLAMP OPEN WHICH HAD CAUSED THE ALARM. THE HP VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER HP, HE DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE HP STATED THAT HE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE HP STATED THAT HE 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 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 38 YR HOMECHOICE