BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 933649 · Received October 3, 2007

    Report

    Report Number
    1423500-2007-01071
    Event Type
    Injury
    Date Received
    October 3, 2007
    Date of Event
    August 31, 2007
    Report Date
    September 4, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): K923065. THE HOME PATIENT HAD BEEN RETRAINED BY THE PD NURSE. IN ADDITION, THE NURSE INCREASED THE PATIENT'S DIANEAL CONCENTRATION TO 4.5% AND THE HP NOW USES HEPARIN TO PREVENT FIBRIN BLOCKAGES DURING THERAPY. THE HP DOES FEEL HIS HOMECHOICE MACHINE CAUSED OR CONTRIBUTED TO HIS BEING OVERFILLED AND HE DID NOT REQUEST A SWAP OF HIS DEVICE. BAXTER IS MONITORING ISSUES LIKE THIS. SHOULD SIGNIFICANT INFORMATION BECAME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PRODUCT SURVEILLANCE WAS INFORMED BY THE HOME PATIENT'S NURSE THAT HE WAS HOSPITALIZED DUE TO DIFFICULTY DRAINING WHICH CAUSED HIM TO BE OVERFILLED WITH SOLUTION. THE HOME PATIENT (HP) WAS THEN CONTACTED AND STATED THAT HE WAS HAVING DIFFICULTY DRAINING DUE TO FIBRIN IN THE PATIENT LINE. THE HP HAD A LAST FILL VOLUME OF 3000 ML. HE STATED THAT HE HAD ONLY DRAINED 800 ML WHEN HE BYPASSED INTO THE FILL CYCLE. HE STATED THAT HE CONTINUED TO PERFORM THERAPY WITH HIS DIFFICULTY DRAINING DUE TO FIBRIN BLOCKAGE. THE HP EXPERIENCED SYMPTOMS OF HEADACHE AND CHEST PAIN AND WENT TO THE HOSPITAL IN 2007. THE HP HAD HEPARIN, BUT DID NOT THINK TO USE IT AT THE TIME THIS OCCURRED. THE HP WAS ADMITTED TO THE HOSPITAL FOR "OVERLOAD" AND WAS EXPERIENCING DISCOMFORT, SHORTNESS OF BREATH, AND THE INABILITY TO LAY DOWN WHEN FULL OF FLUID, ACCORDING TO HIS NURSE. THE PATIENT WAS PLACED ON HEMODIALYSIS TO REMOVE THE EXCESS FLUID CUMULATED AS A RESULT OF INABILITY TO DRAIN AND HIS CATHETER WAS FLUSHED WITH HEPARIN IN OR ORDER TO RESOLVE THE FIBRIN BLOCKAGE. AFTER BEING RELEASED FROM THE HOSPITAL, THE PATIENT HAD BEEN USING HEPARIN IN HIS BAGS AND STATED, HE IS DRAINING AT A FAST RATE AND NOT HAVING ANY ADDITIONAL PROBLEMS WITH THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R