BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMBI-SET

    MDR report key: 3115532 · Received May 9, 2013

    Report

    Report Number
    1225714-2013-00936
    Event Type
    Death
    Date Received
    May 9, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 9, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    KOC
    PMA / PMN Number
    K022536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, A FRESENIUS TECHNICIAN EVALUATED THE MACHINE AND CONFIRMED THE MACHINE TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS. ALTHOUGH REQUESTED ON MULTIPLE OCCASIONS, MEDICAL RECORDS HAVE NOT BEEN PROVIDED FOR REVIEW. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF/WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. A SYSTEM LEVEL INVESTIGATION WAS PERFORMED TO INCLUDE THE DIALYSIS MACHINE, THE DIALYZER, THE BLOODLINE AND CONCENTRATE(S) USED DURING TREATMENT. PRODUCT INVESTIGATIONS INCLUDING EQUIPMENT HISTORY AND LOT BATCH RECORDS DID NOT INDICATE DEVICE MALFUNCTIONS. THE MEDICAL ASSESSMENT PERFORMED BY THE FRESENIUS POST MARKET CLINICAL PHYSICIAN HAS CONCLUDED THE DIALYZER AND BLOODLINES ARE NOT A FACTOR IN THE EVENT. HOWEVER, WITH INFORMATION PROVIDED AS OF THE DATE OF THIS WRITING, AN MDR WILL BE FILED ON THE MACHINE (THIS REPORT) AND CONCENTRATES. PLEASE REFERENCE MDR REPORT NUMBERS: 1225714-2013-00933 AND 00934, REGARDING THE SAME REPORTED PATIENT EVENT.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE USER FACILITY CONTACTED THE FRESENIUS SERVICE DEPARTMENT TO REQUEST A FUNCTIONS CHECK OF A HEMODIALYSIS MACHINE AFTER A PATIENT INCIDENT. THE USER FACILITY REPORTED A PATIENT "CODED" TWO HOURS INTO TREATMENT AND SUBSEQUENTLY EXPIRED. THIS WAS THE PATIENT'S SECOND HEMODIALYSIS TREATMENT. THE USER FACILITY REPORTED, DURING THE TREATMENT ON (B)(6) 2013, THERE WERE NO MACHINE PROBLEMS NOTED OR FLUID REMOVAL PROBLEMS PRIOR TO TREATMENT. DURING DIALYSIS, TREATMENT WAS "RUNNING FINE" AND THERE WAS NO BLOOD LOSS. ON THE MORNING OF TREATMENT, THE PATIENT'S BLOOD PRESSURE "KEPT DROPPING," AND THE "PATIENT WAS VERY ANXIOUS." ATIVAN, UNKNOWN DOSE (MEDICATION) WAS ADMINISTERED TO THE PATIENT ONE HOUR PRIOR TO HER DEATH. NO ALLERGIC REACTIONS OR OTHER EVENTS WERE REPORTED. THE USER FACILITY REPORTED, THE PATIENT "HAD RELAXED AND JUST BECAME UNRESPONSIVE." IT WAS REPORTED BY THE PATIENT'S PHYSICIAN THAT THE PATIENT HAD BEEN "SICK FOR A WHILE." ALSO, ACCORDING TO THE PATIENT'S PHYSICIAN, THE PATIENT HAD A CARDIAC EVENT WHICH CAUSED HER DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204679 COMBI-SET KOC REYNOSA MANUFACTURING 12LR01055

    Patients

    Seq Age Sex Outcome Treatment
    1 Death FRESENIUS DIALYZER 180 NRE LOT #13AU05006| FRESENIUS DIALYSATE| FRESENIUS 2008T HEMODIALYSIS MACHINE