BEUDAMED
    FDA Adverse Event Summary report: N

    SIEMENS MED-RO SYSTEM

    MDR report key: 4200693 · Received October 24, 2014

    Report

    Report Number
    3019131-2014-00030
    Date Received
    October 24, 2014
    Date of Event
    March 28, 2014
    Report Date
    October 24, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K013677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAR COR DELIVERED DI TANKS TO THE CUSTOMER IN AUGUST/SEPTEMBER OF 2013 AS STANDBY TANKS IN CASE THEIR CENTRAL REVERSE OSMOSIS (RO) WENT DOWN. JANUARY 2014 A DI CART WAS DELIVERED TO THE CUSTOMER TO BE USED WITH THE STANDBY TANKS. (B)(6) THE CUSTOMER'S SIEMENS CENTRAL RO SYSTEM ALARMED DUE TO HIGH TOTAL DISSOLVED SOLIDS (TDS). TWO PATIENTS WERE REMOVED FROM TREATMENT AND 3 PATIENTS HAD TREATMENT DELAYED. THE DI TANKS WERE INSTALLED BY THE CUSTOMER TO BE USED WHILE THE RO SYSTEM WAS BEING REPAIRED. ENDOTOXIN SAMPLES OF THE PRODUCT WATER WERE TAKEN AND SENT FOR TESTING. (B)(6) 2014 THE WATER SAMPLE TEST RESULTS TESTED HIGH FOR BACTERIA AND ENDOTOXIN; 61.00 EU/ML AND THE AAMI STANDARD IS LESS THAN 2.0 EU/ML. THE CLINIC BELIEVED THE DI TANKS WERE NOT DELIVERED IN A READY TO USE STATE. UPON INVESTIGATION, IT WAS DETERMINED THE CUSTOMER DID NOT HAVE THE NECESSARY PYROGEN FILTER INSTALLED POST DI PER AAMI/CMS STANDARDS. PER CMS REGULATION V202, ANSI/AAMI RD52:2004 5.2.8 INTERPRETIVE GUIDANCE: WATER TREATED BY DI MAY BE VERY HIGH QUALITY WITH REGARD TO THE ABSENCE OF IONIZED CONTAMINANTS, BUT THE PROCESS DOES NOT REMOVE NONIONIZED SUBSTANCES, INCLUDING BACTERIA AND BACTERIAL ENDOTOXINS... DEIONIZERS ARE AN EFFECTIVE MEANS OF REMOVING IONIC CONTAMINANTS FROM WATER. HOWEVER, THEY DO NOT REMOVE NONIONIC SPECIES (SUCH AS BACTERIA), AND THEY MAY CONTRIBUTE BACTERIAL CONTAMINANTS TO THE WATER... DEIONIZERS OFFER A LARGE SURFACE AREA FOR BACTERIAL PROLIFERATION AND DEIONIZERS GENERALLY CONTRIBUTE TO THE BIOBURDEN IN THE WATER. THE TENDENCY FOR DEIONIZERS TO CONTRIBUTE BACTERIAL CONTAMINANTS TO THE WATER IS GREATER WHEN DEIONIZERS ARE KEPT AS A BACKUP FOR A REVERSE OSMOSIS SYSTEM. CMS REGULATION V204, ANSI/AAMI RD52:2004 5.2.8 STATES: IN ALL INSTANCES, DEIONIZERS SHALL BE FOLLOWED BY AN ULTRAFILTER OR OTHER BACTERIA- AND ENDOTOXIN-REDUCING DEVICE TO REMOVE MICROBIOLOGICAL CONTAMINANTS THAT MAY ORIGINATE IN THE DEIONIZER RESIN BED. SEVEN PATIENTS WERE TREATED WITH PRODUCT WATER HIGH IN BACTERIA AND ENDOTOXINS. THE CUSTOMER INITIATED A MULTIDISCIPLINARY TEAM WHICH REVIEWED ALL PATIENT CHARTS. NO PATIENT ISSUES WERE NOTED. THERE WERE NO REPORTS OF PATIENT ILLNESS OR INJURY AS A RESULT OF THIS INCIDENT. THIS COMPLAINT WILL CONTINUE TO BE MAINTAINED WITHIN MAR COR PURIFICATION'S COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    MAR COR PURIFICATION RECEIVED A LETTER FROM THE CUSTOMER ON 9/24/2014 REGARDING HIGH ENDOTOXIN/BACTERIA READINGS POST DI (DEIONIZED) TANKS ON (B)(6) 2014. SEVEN PATIENTS WERE TREATED WITH DI WATER PRODUCED FROM THESE DI TANKS. THE CLINIC REVIEWED ALL PATIENT CHARTS AND NO PATIENT ISSUES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679545 SIEMENS MED-RO SYSTEM CENTRAL WATER TREATMENT SYSTEM FIP MAR COR PURIFICATION US FILTER MED RO

    Patients

    Seq Age Sex Outcome Treatment
    1