BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE DRY PACK RX-12

    MDR report key: 5245995 · Received November 18, 2015

    Report

    Report Number
    3005162618-2015-00048
    Event Type
    Death
    Date Received
    November 18, 2015
    Date of Event
    October 22, 2015
    Report Date
    March 4, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K981043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, MEDICAL RECORDS AND DEVICE LOT NUMBER WERE NOT PROVIDED.THE SYSTEM LEVEL REVIEW OF THE 2008K2 MACHINE AND CONCOMITANT PRODUCTS FOUND NO INDICATION OF A CAUSAL RELATIONSHIP BETWEEN THE PRODUCTS AND THE PATIENT EVENT.THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE THE MANUFACTURER WITH THE LOT NUMBER OF THE NATURALYTE BICARBONATE USED IN THE REPORTED EVENT. AS NO LOT NUMBER WAS PROVIDED BY THE COMPLAINANT, A RECORD REVIEW WAS PERFORMED ON EACH OF THE LOT NUMBERS SHIPPED TO THE COMPLAINANT IN THE THREE MONTHS LEADING UP TO THE REPORTED EVENT. THE BATCH PRODUCTION RECORDS FOR THESE LOTS WERE REVIEWED. THE PACKAGING COMPONENTS AND CHEMICAL RAW MATERIALS USED IN THE MANUFACTURE OF THE IDENTIFIED LOT WERE REVIEWED. A RETROSPECTIVE RECORD REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCE REPORTS AND/OR ABNORMALITIES DURING THE PRODUCTION OF THE SAP IDENTIFIED LOTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE NATURALYTE BICARBONATE PRODUCT IS MANUFACTURED TO MEET AAMI REQUIREMENTS USING VALIDATED PROCESSES, AND RELEASED BASED ON A DETERMINATION THAT THE FINISHED PRODUCT MET THOSE REQUIREMENTS. A DEFINITIVE CONCLUSION REGARDING THE INVOLVEMENT OF THE PRODUCT COULD NOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF A COMPLAINT SAMPLE. PER THE DOCUMENTED PRODUCT INVESTIGATION, THERE WAS NO INDICATION THAT THE FRESENIUS NATURALYTE BICARBONATE CAUSED, CONTRIBUTED TO OR WAS A FACTOR IN THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE POST MARKET SURVEILLANCE DEPARTMENT HAS REQUESTED MEDICAL RECORDS AND TREATMENT SHEETS FOR THIS REPORTED EVENT BUT NONE HAVE BEEN PROVIDED TO DATE. 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. THE PLANT INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A VOICEMAIL WAS RECEIVED IN FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP'S QUALITY DEPARTMENT REPORTING AN EVENT OF A PATIENT'S CARDIAC ARREST. THE NURSE LEFT HER TELEPHONE NUMBER AND NAME BUT NO OTHER INFORMATION WAS PROVIDED. A FOLLOW UP TELEPHONE CALL WAS PLACED. SPOKE WITH THE CHARGE REGISTERED NURSE (CHARGE RN) WHO CONFIRMED AN EVENT OF CARDIAC ARREST RESULTING IN PATIENT DEATH. BOTH OCCURRED ON (B)(6) 2015. ACCORDING TO THE CHARGE RN, THE FEMALE PATIENT WAS 2.5 HOURS INTO HER HEMODIALYSIS TREATMENT WHEN SHE BECAME UNRESPONSIVE AND HYPOTENSIVE. HER BLOOD WAS RETURNED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE AUTOMATED EXTERNAL DEFIBRILLATOR (AED) PADS WERE PLACED ON THE PATIENT AND IT APPEARED TO MALFUNCTION (NON-FRESENIUS PRODUCT). CPR CONTINUED UNTIL EMERGENCY MEDICAL SERVICES ARRIVED. IT WAS CONTINUED AS THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WHERE, THE CHARGE RN REPORTS, THE PATIENT EXPIRED ON (B)(6) 2015. ADDITIONALLY, THE CHARGE RN STATED THE PATIENT HAD AN ARTERIOVENOUS FISTULA SURGERY PERFORMED ON (B)(6) 2015 AND SHE APPEARED "GROGGY" PRIOR TO DIALYSIS TREATMENT AND WAS VOMITING. THE CHARGE RN ATTRIBUTED THE SYMPTOMS TO THE SURGERY. NO MALFUNCTIONS WERE ALLEGED OR FOUND WITH ANY OF THE PRODUCTS USED DURING THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764999 NATURALYTE DRY PACK RX-12 KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| H| L| R