BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD

    MDR report key: 1943193 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07455
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER REVIEW, THE DATE RECEIVED BY MANUFACTURER FOR THIS REPORT HAS BEEN DETERMINED TO BE (B)(6) 2010. THE DATE OF (B)(6) 2010 NOTED IN THE INTIAL SUBMISSION WAS THE DATE THE NURSE (CUSTOMER) OBSERVED THE EVENT DURING THE EXAMINATION OF THE CARD.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS EVALUATED AND THE ISSUE WAS CONFIRMED. THE CAUSE OF THE OVERFILL EVENT WAS DETERMINED TO BE AN INAPPROPRIATE BYPASS OF THE NEGATIVE ULTRAFILTRATION AND THE LOW DRAIN VOLUME ALARM. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED BY BAXTER (B)(4) FROM (B)(4). A NURSE REPORTED AN OVERFILL EVENT OCCURRED ON THE HOMECHOICE DEVICE WHILE THE HOMEPATIENT WAS IN THE LAST DRAIN. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2010 BY BAXTER (B)(4): THE PROBLEM OCCURRED ON DIALYSIS SESSION OF (B)(6) 2010 AT THE PATIENT'S HOME. ON THE MORNING OF (B)(6) 2010, THE MACHINE STATED "END OF TREATMENT" BUT THE PATIENT HAD 3500ML AFTER DRAIN INSTEAD OF THE USUAL 1500ML. THE NURSE OBSERVED THE EVENT ON (B)(6) 2010 DURING AN EXAMINATION OF THE CARD. THE MACHINE WAS IMMEDIATELY CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1