BEUDAMED
    FDA Adverse Event Death Summary report: N

    U.S. FILTER MED ROS

    MDR report key: 3405662 · Received October 4, 2013

    Report

    Report Number
    3019131-2013-00001
    Event Type
    Death
    Date Received
    October 4, 2013
    Date of Event
    September 2, 2013
    Report Date
    September 4, 2013
    Manufacturer
    SIEMENS (U.S. FILTER)
    Product Code
    FIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT HAS A HISTORY OF CORONARY ARTERY DISEASE AND ACUTE CORONARY SYNDROME. IT IS HIGHLY LIKELY THE DEATH WAS RELATED TO AN "ACUTE CORONARY EVENT". THE PT'S FAMILY DECLINED AN AUTOPSY. THEREFORE, THERE IS NOT ENOUGH EVIDENCE TO SAY WITH COMPLETE CERTAINTY THAT THIS WAS THE CAUSE OF THE EVENT. ON (B)(6) 2013, (B)(4), RN BS, A CLINICAL INVESTIGATION MGR WITH GAMBROS AMERICAS, NOTIFIED (B)(4), VP OF OPERATIONS AT MAR COR PURIFICATION (MCP), OF AN MDR EVENT THAT INVOLVED MAR COR PURIFICATION REVERSE OSMOSIS EQUIPMENT. GAMBROS WAS NOTIFIED ON (B)(6) 2013 BY (B)(6), RN, DIR OF MED CTR OF A PT THAT DIED DURING DIALYSIS. THE EVENT OCCURRED AT (B)(6), DURING THE SECOND SHIFT OF THE DAY. DIALYSIS EQUIPMENT, INCLUDING THE REVERSE OSMOSIS SYSTEM, HAD BEEN USED DURING THE FIRST SHIFT OF THE DAY WITH NO APPARENT ISSUES. PER GAMBROS' EVAL BASED ON INFO PROVIDED BY (B)(6), NO ALARMS WENT OFF DURING THE PT'S DIALYSIS SESSION. MCP CONTACTED ON (B)(6) 2013. MS (B)(6) IDENTIFIED THE MODEL (US FILTER MED RO), SERIAL NUMBER (B)(4) IS A 4 MEMBRANE SYSTEM AND SERIAL NUMBER (B)(4) IS A 5 MEMBRANE SYSTEM), AND MFR (U.S. FILTER, WHICH WAS BOUGHT BY SIEMENS) OF THE TWO RO SYSTEM AT (B)(6). MS (B)(6) CONFIRMED THAT BOTH RO SYSTEMS WERE AND ARE STILL OPERATING PROPERLY AND THAT NO WATER SYSTEM ALARMS WENT OFF DURING THE PT'S DIALYSIS SESSION. SHE ALSO STATED THAT THE RO SYSTEMS HAVE BEEN CONTINUOUSLY USED SINCE (B)(6) 2013, THE DAY OF THE ADVERSE EVENT, WITH NO ISSUES. MCP DID NOT MFR THE RO SYSTEMS USED FOR THE DIALYSIS OF THE PT. HOWEVER, MCP NOTIFIED SIEMENS OF THIS INCIDENT AND COMMUNICATED TO THEM THAT WE WERE SUBMITTING AN MDR BECAUSE ON (B)(6) 2013, MCP PURCHASED THE HEMODIALYSIS WATER BUSINESS FROM (B)(4). IN CONCLUSION, THERE IS NOTHING THAT INDICATES THE RO SYSTEMS CAUSED OR CONTRIBUTED TO THE EVENT. UPON RECEIPT OF ANY ADDITIONAL INFO, MCP WILL REVIEW AND DETERMINE IF A SUPPLEMENTAL REPORT IS NECESSARY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A (B)(6) YR OLD MALE PT PRESENTED HIMSELF FOR DIALYSIS IN HIS USUAL STATE OF HEALTH WITH NO COMPLAINTS. THREE HRS AND 45 MINUTES INTO AN UNEVENTFUL FOUR HR TREATMENT, THE STAFF OBSERVED THAT THE PT APPEARED TO BE SLEEPING, BUT "HIS COLOR DID NOT LOOK RIGHT." THE PT WAS ASSESSED AND FOUND TO BE UNRESPONSIVE. PRIOR TO THIS, THERE HAD BEEN NO MACHINE ALARMS (DIALYSIS OR REVERSE OSMOSIS EQUIPMENT) OR ISSUES. TREATMENT WAS ENDED AND "A CODE WAS CALLED." THE HOSP CODE TEAM ARRIVED AND BEGAN RESUSCITATIVE EFFORTS. THE PT COULD NOT BE RESUSCITATED AND WAS PRONOUNCED DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504184 U.S. FILTER MED ROS REVERSE OSMOSIS (RO) EQUIPMENT/SYSTEMS FIP SIEMENS (U.S. FILTER) U.S. FILTER MED RO

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death