BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 14111986 · Received April 14, 2022

    Report

    Report Number
    1416980-2022-01818
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 20, 2022
    Report Date
    May 13, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION MADE TO D1: BRAND NAME: HOMECHOICE AUTOMATED PD SET WITH CASSETTE (PREVIOUSLY SUBMITTED AS NI). CORRECTION MADE TO D4: CATALOGUE #: L5C4531 (PREVIOUSLY SUBMITTED AS ASKU). CORRECTION MADE TO G1: DEVICE MANUFACTURER NAME: BAXTER HEALTHCARE - MOUNTAIN HOME (PREVIOUSLY SUBMITTED AS BAXTER HEALTHCARE - LARGO). CORRECTION MADE TO G1: DEVICE MANUFACTURER ADDRESS 1: 1900 N HIGHWAY 201 (PREVIOUSLY SUBMITTED AS 7511 114TH AVE. NORTH). CORRECTION MADE TO G1: DEVICE MANUFACTURER CITY: MOUNTAIN HOME (PREVIOUSLY SUBMITTED AS LARGO). CORRECTION MADE TO G1: DEVICE MANUFACTURER STATE: AR (PREVIOUSLY SUBMITTED AS FL). CORRECTION MADE TO G1: DEVICE MANUFACTURER POSTAL CODE: 72653 (PREVIOUSLY SUBMITTED AS 33773). CORRECTION MADE TO G4: PMA/510K #: K102936 (PREVIOUSLY SUBMITTED AS NI). H10: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTEGRATED APD SET W/CASSETTE LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING USE FOR AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY WITH A HOMECHOICE DEVICE. THE EVENT WAS FURTHER DESCRIBED AS THE PATIENT NOTICED A ¿LEAK FROM THE DOOR DURING END OF THERAPY¿. THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE EVENT. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT IN REMOVING THE CASSETTE AND CHECK THE CASSETTE AND GASKET FOR ANY ISSUE AND NO ISSUES WERE SEEN. RTS ADVISED THE PATIENT TO FOLLOW UP WITH THEIR REGISTERED NURSE. RTS DISCUSSED CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WITH THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108002 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown HOMECHOICE PRO| UNSPECIFIED PD SOLUTION