BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2243312 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12056
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 27, 2011
    Report Date
    August 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). THIS COMPLAINT FOR AIR OBSERVED IN THE SUPPLY LINE, THOUGH THIS DID NOT CAUSE OF THE CHECK SUPPLY LINE ALARM, WAS NOT CONFIRMED AND THE ASSIGNABLE CAUSE WAS NOT DETERMINED. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN AT THIS TIME; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING AIR IN THE SUPPLY LINE DURING A CHECK SUPPLY LINE ALARM WHILE IN FILL 2 OF 4 ON THE HOME CHOICE (HC). THE HC HAD SOME SOLUTION IN THE SUPPLY BAG ONLY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HOME PATIENT (HP) TO LIFT THE SUPPLY BAG AND PRESS GO. THE HC WAS BACK TO REFILLING THE HEATER. THE HEATER BAG WAS NOT REFILLING. THE TSR INSTRUCTED THE HP TO PUSH THE SOLUTION IN TO THE CASSETTE. THE HP STATED THERE WAS AIR IN THE SUPPLY LINE. THE TSR ASSISTED WITH ENDING THERAPY IN FILL 2 OF 4 WITH A FILL VOLUME (FV)=1070ML. PRODUCT SURVEILLANCE (PS) CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) ON (B)(6) 2011 REGARDING THE CHECK SUPPLY LINE ALARM WITH AIR IN THE LINE. PER THE PD RN, THEY WERE CONTACTED BY THE HOME PATIENT (HP) REGARDING THE ALARM AND AIR IN THE LINE. THE PD RN STATED THE HP IS CURRENTLY USING THE CYCLER WITHOUT PROBLEMS. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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 85 YR HOMECHOICE