BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 4840339 · Received June 12, 2015

    Report

    Report Number
    8030665-2015-00284
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    May 9, 2014
    Report Date
    May 20, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    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. INFO REVIEWED. BASED ON THE 4 PAGES OF MEDICAL RECORDS APPEARS THAT THE PATIENT EXPIRED FROM ASPIRATION PNEUMONIA ON (B)(6) 2014. MEDICAL RECORDS SHOW THAT NO IIPV OCCURRED PRIOR TO THIS EPISODE. ACCORDING TO THE PATIENT'S WIFE, THE PATIENT WAS ON DIALYSIS ON (B)(6) 2014, HE FELT NAUSEOUS AND THEN VOMITED. HIS VOMIT CAME BACK INTO HIS LUNGS AND CREATED A COMPLICATION THAT LED HIM TO BE HOSPITALIZED. THE PATIENT WAS DIAGNOSED WITH PNEUMONIA AT THE HOSP. HE CONTINUED DIALYSIS EVERY 6 HOURS AT THE HOSP. THE PATIENT WAS SUBSEQUENTLY MOVED TO THE INTENSIVE CARE UNIT AS HE COULD NOT GET THE MUCUS OUT OF HIS THROAT AND HAD TROUBLE BREATHING. ACCORDING TO THE WIFE, ON (B)(6) 2014, THE PATIENT'S HEART HAD STOPPED AND HE PASSED AWAY. HOWEVER, THE DEATH CERTIFICATE READS THE PATIENT EXPIRED ON (B)(6) 2014. THE PERITONEAL DIALYSIS REGISTERED NURSE DID NOT KNOW IF THE PATIENT WAS USING FRESENIUS PRODUCTS AT THE TIME OF THE PASSING. SHE ALSO DID NOT KNOW IF HE WAS ON HEMODIALYSIS OR PERITONEAL DIALYSIS THERAPY AT THE TIME OF DEATH. THERE IS NO DOCUMENTATION IN THE MEDICAL RECORD THAT SHOWS ANY CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S VOMITING EPISODE AND THE PATIENT'S DIALYSIS TREATMENT/PRODUCTS. THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. NO SERIAL OR LOT NUMBER WAS PROVIDED, THEREFORE NO BATCH RECORD OR LABELING REVIEW WERE CONDUCTED.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT'S WIFE REPORTED THAT WHILE HER HUSBAND WAS ON DIALYSIS ON (B)(6) 2014, HE FELT NAUSEOUS AND THEN VOMITED. HIS VOMIT CAME BACK INTO HIS LUNGS AND CREATED A COMPLICATION THAT LED HIM TO BE HOSPITALIZED. THE PATIENT WAS DIAGNOSED WITH PNEUMONIA AT HOSP. AT THE HOSP, THE PATIENT DID MANUAL DIALYSIS TREATMENT EVERY 6 HOURS. THE PATIENT WENT TO THE INTENSIVE CARE UNIT AS HE COULD NOT GET THE MUCUS OUT OF THIS THROAT AND HAD TROUBLE BREATHING. ON (B)(6) 2014, THE PATIENT'S HEART HAD STOPPED AND HE PASSED AWAY. PATIENT WAS ON DIALYSIS TREATMENT DURING THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385587 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX FKX FRESENIUS MEDICAL CARE NORTH AMERICA 050-87216 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H