BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2822137 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04248
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT 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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE HOMECHOICE CYCLER WAS EVALUATED BY THE LARGO PRODUCT ANALYSIS LAB (PAL). THE REPORTED CONDITION OF A SYSTEM ERROR (SE) 2130 ALARM WAS CONFIRMED IN THE DEVICE LOGS, BUT WAS NOT DUPLICATED DURING PAL EVALUATION. THE ASSIGNABLE CAUSE WAS UNDETERMINED. PAL RECOMMENDED SCRAPPING THE DIGITAL PRINTED CIRCUIT BOARD. THE DEVICE WAS SENT TO SERVICING.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2130 ON A HOMECHOICE (HC) DEVICE DURING DRAIN 4 OF 5, PATIENT CONNECTED, INDICATING THAT THE DEVICE HAS DELIVERED MORE THAN 30 ML IN EXCESS OF THE PROGRAMMED VOLUME. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO CLEAR THE ALARM AFTER WHICH THE HC ALARMED WITH SE2446. THE TSR INITIATED A SWAP OF THE DEVICE. THE HP WILL CONTACT THE NURSE TO PROGRAM THE NEW HC. THE TSR DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) UNTIL THE NEW MACHINE ARRIVES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1