BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3984513 · Received August 6, 2014

    Report

    Report Number
    1416980-2014-25459
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. REVIEW OF THE SERVICE HISTORY REVEALED PREVIOUS DEVICE SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE CAUSE OF THE REPORTED EVENT WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY/SERVICE HISTORY RECORD REVIEW WILL BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) EXPERIENCED A HIGH DRAIN 104 ALARM ON A HOMECHOICE (HC) DEVICE DURING AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THIS ALARM IDENTIFIES THAT THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME, INDICATING AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT. THE ALARM OCCURRED AFTER THERAPY. THE THERAPY LOGS INDICATED THAT THE ULTRAFILTRATION (UF) READING IN CYCLE 4 WAS 2167ML WHILE ONLY HAVING A FILL VOLUME OF 2000ML. NOTHING UNUSUAL WAS NOTED DURING TROUBLESHOOTING FOR THE ALARM. THE HP TAPES THE CATHETER, AND A TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO LOOSEN THE TAPE. THE HP CLEARED THE ALARM AND WAS ABLE TO CONTINUE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459854 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR