BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUID BICARBONATE NATURALYTE 8L

    MDR report key: 3922233 · Received May 23, 2014

    Report

    Report Number
    1225714-2014-03409
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K071387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET CLINICAL DEPARTMENT HAS MADE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HOWEVER, NONE HAS BEEN PROVIDED. THE PATIENT REPORTED FEELING NAUSEOUS AND UNWELL. DUE TO THE REPORTED LOT NUMBER AND ASSOCIATED RECALL; A MALFUNCTION MDR WILL BE SUBMITTED. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. RELATED MEDWATCHES: 1225714-2014-03402, 03403, 03404, 03405, 03406, 03407, 03408, AND 03409.

    Description of Event or Problem · 1

    A HOME DIALYSIS NURSE FROM (B)(6) REPORTS A HOME HEMODIALYSIS PATIENT'S WIFE REPORTED TO HER THAT HER HUSBAND HAD BEEN EXPERIENCING SYMPTOMS OF NAUSEA AND OVERALL FEELING, UNWELL BETWEEN (B)(6) 2014 AND (B)(6) 2014. HE HAD COMPLETED 8 RUNS OF DIALYSIS SINCE ROUGHLY (B)(6) 2014 AND AFTER ONE OF HIS TREATMENTS, HE FELT NAUSEOUS AND FELT THAT HE WAS GOING TO VOMIT, BUT DID NOT. AFTER OTHER TREATMENTS, HE DID NOT FEEL NAUSEOUS BUT GENERALLY UNWELL. HE HAS HAD NO SYMPTOMS OF CHILLS, FEVER, OR HYPOTENSION. AFTER HIS TREATMENT ON (B)(6) 2014 HE FELT "OFF." HIS TEMPERATURE WAS CHECKED AND THERE WAS NO FEVER, NO CHILLS. THERE IS NO ADDITIONAL INFORMATION REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307143 LIQUID BICARBONATE NATURALYTE 8L KPO FRESENIUS MEDICAL CARE NORTH AMERICA 14AMLB011

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS BLOODLINES| FRESENIUS K@HOME HEMODIALYIS MACHINE| FRESENIUS DIALYZER| FRESENIUS SALINE| FRESENIUS ACID