BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD

    MDR report key: 1932569 · Received December 18, 2010

    Report

    Report Number
    1423500-2010-07036
    Event Type
    Death
    Date Received
    December 18, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICE AVAILABILITY IS UNKNOWN. IF THE DEVICE SHOULD BE RETURNED, AN EVALUATION WILL BE PERFORMED AND A FOLLOW MDR SUBMITTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). AS DEVICE WASN'T AVAILABLE FOR INVESTIGATION THERE IS NO INFORMATION TO EVALUATE AND DETERMINE ROOT CAUSE OF CURRENT DRAINING ISSUE COMPLAINT. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A UK ORIGINATED REPORT WHERE THE DAUGHTER OF A HOME PATIENT(HP) ON (B)(6) 2010 CALLED BAXTER (B)(4) TECHNICAL SERVICES(BTS) AND REPORTED THAT THE HP HAD EXPIRED ON (B)(6) 2010. THE HOMECHOICE(HC) (B)(4) WAS IMPLICATED IN THE HP'S DEATH. THE CUSTOMER IS NOT PREPARED TO RELEASE THE HC. THE CUSTOMER WILL HAVE AN INDEPENDENT EXAMINATION PERFORMED ON THE HC. THE DAUGHTER STATED THAT HER MOTHER HAD TWO NIGHTS OF VARIOUS ALARMS BEFORE SHE EXPIRED. ON (B)(6) 2010, A BAXTER (B)(4) REPRESENTATIVE SPOKE WITH THE NURSE WHO STATED THAT THE HP WAS ADMITTED TO THE HOSPITAL AND DID HAVE A NUMBER OF DRAIN ALARMS WITH THE HC, BUT THAT THE DAUGHTER WAS LOOKING FOR SOMEONE TO BLAME. SHE FURTHER STATED THAT THE HP DIED DUE TO AN UNRELATED ISSUE. THE PATIENT'S NURSE WILL CONTACT BAXTER WHEN THE MACHINE CAN BE COLLECTED FOR EVALUATION.

    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 Death