BEUDAMED
    FDA Adverse Event Other Summary report: N

    Z-SERIES REVERSE OSMOSIS SYSTEM

    MDR report key: 2773518 · Received September 28, 2012

    Report

    Report Number
    3019131-2012-00001
    Event Type
    Other
    Date Received
    September 28, 2012
    Date of Event
    August 29, 2012
    Report Date
    September 27, 2012
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K964539
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, MAR CO PURIFICATION (MCP) PERFORMED A MONTHLY MAINTENANCE ON THE Z-SERIES RO SYSTEM AT (B)(6) THAT INCLUDED DISINFECTING THE SYSTEM. AT THE COMPLETION OF THE PROCESS, THE MCP FIELD SERVICE REP INADVERTENTLY CONNECTED THE CONCENTRATE LINE TO THE RO LOOP AND THE PERMEATE LINE TO THE DRAIN. HE ALSO FORGOT TO RE-CONNECT THE FINAL LOOP CONDUCTIVITY METER, WHICH WAS DISCONNECTED FOR THE DISINFECTION PROCESS. IN ADDITION, HE DID NOT TEST THE UNIT AFTER HE WAS COMPLETED WITH THE DISINFECTION TO ENSURE IT WAS CONNECTED CORRECTLY. FURTHER INVESTIGATION REVEALED THAT THE RO HAD ITS REMOTE ALARM WIRE CUT AND USER ERROR ALSO CONTRIBUTED TO THE DELAY OF DETECTION OF THE PROBLEM. HISTORICALLY, THIS MCP FIELD SVC REP HAD PERFORMED THIS MAINTENANCE PROCEDURE SUCCESSFULLY NUMEROUS TIMES. SINCE THIS EVENT OCCURRED, HE HAS BEEN DISMISSED FROM MCP EMPLOYMENT. TO ENSURE THIS SITUATION DOES NOT OCCUR AGAIN IN THE FUTURE AT (B)(6), THE FOLLOWING STEPS HAVE BEEN TAKEN TO MODIFY THEIR Z-SERIES RO: INSTALLED NEW FINAL LOOP CONDUCTIVITY METER THAT DOES NOT HAVE TO BE UNPLUGGED DURING DISINFECTION; CHANGED RO HOSE CONNECTIONS SO THE RO PERMEATE CANNOT BE SWITCHED WITH THE RO CONCENTRATE; INSTALLED A REMOTE ALARM FOR THE RO IN THE CLINIC; REVIEWED RO ALARMS TO ENSURE THERE IS A COMPLETE, APPROPRIATE ALARM SYSTEM IN THE CLINIC.

    Description of Event or Problem · 1

    FOUR TO FIVE PTS WERE DIALYZED WITH REVERSE OSMOSIS WATER CONCENTRATE FROM THREE HOURS AND 35 MINS BEFORE IT WAS NOTICED THAT THE REVERSE OSMOSIS WATER CONCENTRATE LINE WAS SWITCHED WITH THE REVERSE OSMOSIS WATER PERMEATE LINE. THEIR TREATMENTS WERE DISCONTINUED (SHORTENED) WHEN THIS ISSUE WAS NOTED. NONE OF THE DIALYSIS MACHINES (FRESENIUS (B)(4)) USED TO TREAT THESE PTS ALARMED DURING THEIR TREATMENT, WHICH INDICATES THAT THE DIALYSATE SOLUTION USED TO TREAT EACH PT WAS WITHIN THE CONDUCTIVITY SPECIFICATION. NO PTS TREATED HAD ANY ADVERSE REACTION TO THEIR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-SERIES REVERSE OSMOSIS SYSTEM REVERSE OSMOSIS (RO) SYSTEM FIP MAR COR PURIFICATION Z-10,000 SERIES RO NA

    Patients

    Seq Age Sex Outcome Treatment
    1