BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIQUID BICARBONATE 4000 FMC 3 BOT/CS

    MDR report key: 5354368 · Received January 8, 2016

    Report

    Report Number
    1225714-2016-00002
    Event Type
    Death
    Date Received
    January 8, 2016
    Date of Event
    May 27, 2015
    Report Date
    February 4, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K071387
    Removal / Correction Number
    Z-1827-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE POST MARKET SURVEILLANCE DEPARTMENT IS IN THE PROCESS OF REQUESTING PATIENT MEDICAL RECORDS AND TREATMENT DATA INFORMATION REGARDING THE REPORTED EVENT OF DEATH. NO INFORMATION WAS RECEIVED OF A SUSPECTED PYROGEN REACTION OR BACTEREMIA ASSOCIATED WITH THIS EVENT. THE PLANT INVESTIGATION IS IN PROGRESS. A CAPA WAS INITIATED TO ADDRESS THIS ISSUE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WITH RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, MEDICAL INFORMATION AND TREATMENT RECORDS WERE NOT RECEIVED. A SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION REVEALED LOT # 14LMLB010 WAS RECALLED ON MAY 15, 2015. A DEFINITIVE CONCLUSION REGARDING THE INVOLVEMENT OF THE PRODUCT COULD NOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF A COMPLAINT SAMPLE. A RETROSPECTIVE REVIEW OF THIS LOT DID NOT IDENTIFY ANY NONCONFORMANCE REPORTS AND/OR ABNORMALITIES DURING THE PRODUCTION OF THE SAP IDENTIFIED LOT THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    A PATIENT'S SPOUSE REPORTED VIA A BUSINESS REPLY MAIL THAT THE PATIENT EXPIRED ON (B)(6) 2015. THE SPOUSE REPORTED THE PATIENT'S DEATH OCCURRED "SHORTLY AFTER USING 2 CASES OF 14LMLB IN HER DIALYSIS." NO OTHER INFORMATION WAS PROVIDED. FOLLOW UP WAS ATTEMPTED WITH THE PATIENT'S OUTPATIENT DIALYSIS FACILITY FOR FURTHER INFORMATION HOWEVER, THE FACILITY ADMINISTRATOR STATED SHE COULD NOT DISCLOSE ANY INFORMATION. NO SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12333 LIQUID BICARBONATE 4000 FMC 3 BOT/CS DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO FRESENIUS MEDICAL CARE NORTH AMERICA 14LMLB010

    Patients

    Seq Age Sex Outcome Treatment
    1 Death