BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2240624 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11926
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    September 5, 2011
    Report Date
    September 5, 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING DWELL 2/3 WAS CONFIRMED. THE BAG BECAME DISCONNECTED. THE HP STATED THAT SHE DID NOT CONNECT THE SUPPLY ALL THE WAY AND THAT IS WHY IT BECAME DISCONNECTED. 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. THIS ISSUE HAS BEEN ESCALATED TO CAPA. THE ASSIGNABLE CAUSE WAS LOOSE CONNECTION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH THE HOMECHOICE (HC) UNIT DURING DWELL 2 OF 3. PER THE INITIAL REPORT, HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN THE LINE). THE HP WAS CONNECTED. THE BAG BECAME DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) RECYCLED THE POWER AND CLEARED AND EXPLAINED THE ALARM. THE CALLER WOULD DISCARD THE SUPPLIES AND FINISH WITH MANUALS. GLOBAL PRODUCT SURVEILLANCE CONTACTED HP ON (B)(6) 2011. THE HP DID NOT COMPLETE THERAPY THAT NIGHT BUT DID A MANUAL EXCHANGE THE FOLLOWING DAY. THE HP DID NOT NOTICE ANY DEFECTS WITH THE ORIGINAL CASSETTE. THE HP STATED THAT SHE DID NOT CONNECT THE SUPPLY BAG ALL THE WAY AND THAT IS WHY IT BECAME DISCONNECTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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 86 YR HOMECHOICE