BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4846638 · Received June 15, 2015

    Report

    Report Number
    2937457-2015-01180
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    April 27, 2015
    Report Date
    May 12, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PLANT'S INVESTIGATION AND CLINICAL INVESTIGATION OF MEDICAL RECORDS.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REPORTED A PATIENT WAS HOSPITALIZED FOR PLEURAL EFFUSION. THE FOLLOWING IS BASED ON THE MEDICAL RECORDS RECEIVED FROM THE PATIENT'S TREATMENT FACILITY. THE PATIENT PRESENTED WITH A THREE DAY HISTORY OF INCREASING SHORTNESS OF BREATH WITH ASSOCIATED DRY COUGH AND CHILLS. HE DENIED FEVER, CHEST PAIN, DIARRHEA OR HEMATOCHEZIA. THE PATIENT HAD DIFFICULTY WITH HIS PD CATHETER AND INCOMPLETE DRAINING. THE PATIENT ALSO DESCRIBED SHARP LOWER ABDOMINAL PAIN WITHOUT CLEAR PRECIPITANT AND WAS RELIEVED WITH PASSING GAS. HE WAS UNABLE TO SLEEP SECONDARY TO SEVERE PAROXYSMAL NOCTURNAL DYSPNEA (PND) AND ORTHOPNEA. CHEST X-RAY SHOWED LARGE RIGHT PLEURAL EFFUSION TREATED WITH THORACENTESIS. THE PATIENT WAS INITIALLY TREATED ON PERITONEAL DIALYSIS THEN SWITCHED TO HEMODIALYSIS BEFORE BEING DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. THE PDRN STATED IT WAS UNKNOWN IF THE PLEURAL EFFUSION WAS PRODUCT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388013 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R ASPIRIN| COLACE| MIRALAX| LOSARTAN| HYDROCODONE WITH ACETAMINOPHEN| OMEPRAZOLE| PERITONEAL DIALYSIS DELFLEX SOLUTION| PROZAC| ROCALTROL| HYDRALAZINE| LIBERTY CYCLER CASSETTE| VITAMIND| MULTIVITAMIN| LANTUS INSULIN| LABETALOL| ZOCOR