BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2915827 · Received January 15, 2013

    Report

    Report Number
    1416980-2013-01027
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 22, 2012
    Report Date
    December 22, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A EVALUATION OF THE ACTUAL SAMPLE WAS CONDUCTED AND THE CONDITION WAS CONFIRMED. A VISUAL INSPECTION WAS PERFORMED AND REVEALED THAT THERE WAS A SMALL SPLIT ON THE HEATER LINE, IN THE TACKLE WELD AREA. A FUNCTIONAL INSPECTION WAS PERFORMED AND THOUGH NO ALARMS WERE FOUND, SOLUTION WAS DRIPPING FROM THE HEATER LINE SPLIT. HOWEVER, THE ROOT CAUSE FOR THE SPLIT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE SAMPLE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICES CENTER REGARDING A CHECK HEATER LINE ALARM, WHICH OCCURRED ON THE HOME CHOICE (HC) DURING FILL 1. THE CARE GIVER (CG) STATED THAT SHE PULLED DOWN ON LINES AT HC DOOR AND THE HEATER LINE HAD A SMALL HOLE AND WAS LEAKING RIGHT AT THE HC DOOR. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG TO END THERAPY AND ADVISED THE CG TO START OVER WITH NEW SUPPLIES AND ADVISED THE CG TO SAVE THE CASSETTE FOR PICKUP. THE CG STARTED OVER WITH NEW SUPPLIES AND SAVED THE CASSETTE FOR PICKUP. THE SOLUTION TO THIS ISSUE AS PROVIDED OVER THE PHONE AND SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE RECEIVED A CALL FROM THE HOME PATIENT'S CAREGIVER ON (B)(6) 2012 AND SHE SAID THE PATIENT WAS ABLE TO RESUME THERAPY THAT DAY AFTER STARTING OVER WITH NEW SUPPLIES. SHE ALSO SAID THAT THEY HAD ANOTHER ISSUE WITH A CASSETTE FROM THE SAME BOX AS THE ONE THAT LEAKED WHERE THE CASSETTE FAILED THE OTHER NIGHT IN SELF-TEST. THE PATIENT WAS NOT CONNECTED. SHE SAID SHE DID NOT HEAR AN ALARM, JUST THAT THE MACHINE WOULD NOT PROCEED INTO PRIME. THEY RESTARTED OVER WITH NEW SUPPLIES AND SHE SAID THE PATIENT WAS ABLE TO COMPLETE THERAPY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23119 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H12F17460

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOME CHOICE