BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 5999641 · Received October 5, 2016

    Report

    Report Number
    8030665-2016-00532
    Event Type
    Death
    Date Received
    October 5, 2016
    Date of Event
    September 26, 2016
    Report Date
    November 3, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW; WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT¿S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    COMPLAINT SAMPLE WAS NOT AVAILABLE, AND THE LOT NUMBER OF PRODUCT INVOLVED IN THIS INCIDENT WAS UNKNOWN. HOWEVER, SALES AND SHIPPING SEARCH TO THE CLIENT WITHIN THE TIME FRAME OF THREE MONTHS BEFORE THE DATE OF OCCURRENCE WAS PERFORMED. ACCORDING TO OUR RECORDS NO PRODUCT IS AVAILABLE FROM THESE LOTS ON DISTRIBUTION CENTERS TO BE ANALYZED. THE ENTIRE LOTS HAVE BEEN SOLD AND DISTRIBUTED. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT'S CONTACT REPORTED THAT THE PATIENT PASSED AWAY WHILE CONNECTED TO THERAPY. THE CAREGIVER REPORTED THAT SHE HEARD THE PATIENT MOANING AT 0500 HRS, FOUND THE PATIENT HAD BEEN INCONTINENT AND WAS RESPONSIVE. A FEW HOURS LATER THE CAREGIVER RETURNED TO DISCONNECT THE PATIENT AND FOUND HER UNRESPONSIVE. THE EMERGENCY MEDICAL SERVICES WERE CALLED AND THEY WERE UNABLE TO RESUSCITATE THE PATIENT. DURING FOLLOW UP WITH THE PATIENT'S NURSE IT WAS REPORTED THE PATIENT'S CAUSE OF DEATH WAS HER CHRONIC ILLNESSES. THE NURSE ALSO REPORTED THAT THE PATIENT HAD COMPLAINED OF SHOULDER PAIN THE PREVIOUS NIGHT BEFORE CONNECTING TO THE CYCLER FOR PERITONEAL DIALYSIS TREATMENT. MEDICAL RECORDS HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651904 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DELFLEX PD SOLUTIONS