BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 5795727 · Received July 14, 2016

    Report

    Report Number
    2937457-2016-00724
    Event Type
    Injury
    Date Received
    July 14, 2016
    Date of Event
    June 28, 2016
    Report Date
    July 29, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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. CLINICAL REVIEW OF THE MEDICAL RECORDS DOES NOT REVEAL ANY ALLEGATION AGAINST ANY FRESENIUS PRODUCTS. THE ACUTE METABOLIC ENCEPHALOPATHY DUE TO POLYPHARMACY, LACTIC ACIDOSIS, ACUTE PROLONGED QTC THAT WAS POSSIBLY DRUG RELATED, ACUTE URINARY RETENTION WERE UNLIKELY RELATED TO PERITONEAL DIALYSIS WITH FRESENIUS PRODUCTS AND LIKELY RELATED TO THE PATIENT¿S POLYPHARMACY AND AGE (URINARY RETENTION).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. DEVICE HISTORY REVIEW WAS PERFORMED AND FOUND NO NON-CONFORMANCE REPORTS OR OTHER ABNORMALITIES DURING THE MANUFACTURING PROCESS. THE PRODUCT INVOLVED MET CURRENT SPECIFICATIONS. IN ADDITION, THE DEVICE RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THE SYSTEM LEVEL REVIEW OF THE LIBERTY CYCLER AND CONCOMITANT PRODUCTS FOUND NO INDICATION OF A CAUSAL RELATIONSHIP BETWEEN THE PRODUCTS AND THE PATIENT EVENT.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT CALLED TECHNICAL SERVICES FOR ASSISTANCE DISCONNECTING, WAS DISORIENTATED, AND HAD AN AMBULANCE ARRIVE. DURING FOLLOW-UP WITH THE PD NURSE REPORTED THE PATIENT WAS ADMITTED FOR ALTERED MENTAL STATUS. SHE REPORTED THE PATIENT WAS ON LONG TERM PAIN MEDICATIONS. SHE ALSO REPORTED THERE WERE NO ELECTROLYTE IMBALANCES AND HIS PD FLUID SHOWED NO SIGN OF INFECTION. DURING ADMISSION THE PATIENT WAS FOUND TO HAVE ACUTE METABOLIC ENCEPHALOPATHY DUE TO POLYPHARMACY, LACTIC ACIDOSIS, ACUTE PROLONGED QTC THAT WAS POSSIBLY DRUG RELATED AND ACUTE URINARY RETENTION (TO BE TREATED WITH FLOMAX). IN ADDITION THE PATIENT HAD PHYSICAL DECONDITIONING THAT OCCURRED DURING ADMISSION THAT WAS TREATED WITH PHYSIOTHERAPY. DISCHARGED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449698 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R