BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2864041 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06828
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    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). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS OPERATIONAL AND WAS NOT RETURNED FOR EVALUATION. THE PRODUCT ANALYSIS LAB (PAL) CONFIRMED THE REPORTED HIGH DRAIN/CALL PD NURSE ALARM, WHICH INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME (MEETING INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA BASED ON THE REPORTED INFORMATION). THE ASSIGNABLE CAUSE OF THE IIPV WAS UNDETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A HIGH DRAIN 103/CALL PD NURSE ALARM (INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME, MEETING INCREASED INTRA-PERITONEAL VOLUME (IIPV) CRITERIA), WHICH OCCURRED ON THE HOMECHOICE (HC) AFTER USE. THE HOME PATIENT (HP) WAS AT THE END OF THERAPY. THEY STATED THEY ALREADY SPOKE TO THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PDRN HAD THE HP CYCLE THE POWER AND THEY WERE STILL GETTING THE MESSAGE. THEY CLEARED IT. THE LAST FILL VOLUME WAS EQUAL TO 3080ML. THE CYCLE 5 ULTRAFILTRATION (UF) WAS EQUAL TO 634ML, THE CYCLE 4 UF WAS EQUAL TO 595ML, THE CYCLE 3 UF WAS EQUAL TO 1429ML, THE CYCLE 2 UF WAS EQUAL TO -139ML, AND THE CYCLE 1 UF WAS EQUAL TO 561ML. THE HP USED RED BAGS LAST NIGHT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE ALARM LOG. THE HP SLEPT THROUGH THE ENTIRE THERAPY. THERE WERE NO ALARMS. THE HP DIDN'T WANT TO ANSWER ANY FURTHER QUESTIONS. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE (PS) SPOKE WITH THE REGISTERED NURSE (RN) ON (B)(4) 2012, REGARDING THE REPORTED ALARM. THE NURSE STATED THAT SHE WAS AWARE OF THE EVENT. SHE STATED THAT THE PATIENT HAS BEEN ABLE TO CONTINUE THERAPY ON THE CYCLER SUCCESSFULLY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ALLEGATIONS WERE MADE AGAINST ANY BAXTER PRODUCTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE