BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2884170 · Received December 21, 2012

    Report

    Report Number
    1416980-2012-07995
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 1, 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). THE PROBLEM WAS CONFIRMED. THE ROOT CAUSE WAS USE ERROR. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK SUPPLY LINE ALARM WHILE REFILLING THE HEATER. THIS OCCURRED ON A HOMECHOICE (HC) DURING A LAST FILL. THE HOME PATIENT (HP) THOUGHT THERE WAS A LEAK. THE HP STATED ONE OF THE BAGS WAS NOT CONNECTED COMPLETELY IN THE SETUP AND THE BAG LEAKED. THE HP NOTED SOME SOLUTION WAS ON THE FLOOR. THE TSR ADVISED IF THERE WERE LEAKS, TO START OVER WITH NEW SUPPLIES. THE TSR RECOMMENDED THE HP CONTACT THE REGISTERED NURSE (RN). THE HP STATED THE BAG WAS NOT CONNECTED ALL THE WAY. THE HP STATED THE BAGS TWIST TOGETHER AND MAY NOT BE CONNECTED COMPLETELY. THE TSR ASSISTED WITH TROUBLESHOOTING AND ASSISTED THE HP TO END THERAPY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT ON (B)(6) 2012. THE HP SAID THAT HE DID NOT CONNECT THE LINE TO THE BAG COMPLETELY. HE SAID THERE WAS NOTHING WRONG WITH THE SUPPLIES. NO FURTHER INFORMATION WAS AVAILABLE.

    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 H12F27030

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR HOME CHOICE