BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2230499 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11523
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 14, 2011
    Report Date
    August 14, 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 SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN AT THIS TIME; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. 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) WAS CONFIRMED AND THE CAUSE WAS IDENTIFIED. THE PATIENT STATED THEIR CATS PUT A HOLE IN THE LINE WHICH CAUSED THE ALARM AND WOULD HAVE ALLOWED AIR TO END THE SYSTEM. THIS REVIEW FINDS THE TRAINING AND LABEL MATERIALS ADEQUATE RELATED TO THE USE/USER ERROR. 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 (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN THE SET) DURING DRAIN 3 OF 3 ON THE HOME CHOICE (HC). THE HOME PATIENT (HP) STATED SHE HAD PETS AND THERE WAS A PUNCTURE IN ONE OF THE SUPPLY LINES THAT WAS LEAKING ALL OVER FLOOR. THE HP ALSO STATED SHE HAD DISCONNECTED AFTER THE ALARM OCCURRED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO CYCLE POWER TWICE AND THE HC WAS AT PRESS GO TO START. THE TSR INSTRUCTED THE HP TO REMOVE THE CASSETTE TO DISCARD THE SUPPLIES. THE TSR EXPLAINED THE ALARM AND ASSISTED THE HP TO CLEAR THE ALARM. THE HP STATED SHE WOULD DO A MANUAL EXCHANGE IN THE MEANTIME. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. PER THE HP, THE SUPPLIES WERE DISCARDED AND THE LOT NUMBER WAS NOT KNOWN. THE HP STATED HER CATS PUT A HOLE IN THE LINE TO CAUSE THE ALARM. THE HP USED MANUAL SUPPLIES THE NIGHT OF THE ALARM AND RESUMED THERAPY THE FOLLOWING NIGHT ON THE CYCLER. THE HP NOW DOES THERAPY IN A DIFFERENT ROOM WITH THE DOOR CLOSED AND THE CATS ARE LOCKED OUT. THE HP STATED SHE CONTACTED HER PERITONEAL DIALYSIS NURSE ABOUT THE ALARM AND WAS GIVEN AN ANTIBIOTIC.

    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 51 YR HOMECHOICE