BEUDAMED
    FDA Adverse Event Injury Summary report: N

    23G SERIES REVERSE OSMOSIS SYSTEM

    MDR report key: 8471404 · Received April 1, 2019

    Report

    Report Number
    3019131-2019-00005
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    March 9, 2019
    Report Date
    April 1, 2019
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K931595
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY REPORTED 6-8 PATIENTS BECOMING SICK DURING DIALYSIS TREATMENT USING THE 23G REVERSE OSMOSIS WATER PURIFICATION SYSTEM. ALL PATIENT TREATMENTS WERE DISCONTINUED AND ONE PATIENT SOUGHT MEDICAL ATTENTION AFTER PRESENTING SYMPTOMS OF DIZZINESS AND CRAMPS. IN COMMUNICATION WITH MAR COR PURIFICATION FIELD SERVICE TECHNICIAN, THE FACILITY'S NURSE MANAGER REPORTED HIGH CHLORINE LEVELS WERE DETECTED IN THE PRODUCT WATER AT THE END OF THE LOOP (POST RO SYSTEM). MAR COR PURIFICATION FIELD SERVICE TECHNICIAN VISITED THE FACILITY THE FOLLOWING DAY AND PERFORMED A COMPLETE CHECK OF THE WATER ROOM EQUIPMENT. CHLORINE TESTS WERE PERFORMED ON PRIMARY AND SECONDARY CARBON FILTERS AS WELL AS THE END OF THE LOOP. ALL RESULTS SHOWED THE SYSTEM WAS OPERATING WITHIN SPECIFICATION. MAR COR PURIFICATION REGULATORY FOLLOWED UP WITH THE FACILITY'S NURSE MANAGER AND IT WAS CONFIRMED THAT THE SYSTEM WAS OPERATING NORMALLY AND THERE HAVE BEEN NO ISSUES SINCE THE REPORTED INCIDENT. THE CAUSE OF THE PATIENTS BECOMING SICK HAS NOT BEEN DETERMINED. THE NURSE MANAGER CONFIRMED ALL THE PATIENTS ARE DOING FINE AND ARE CONTINUING TREATMENT. MAR COR PURIFICATION HAS RECEIVED NO SIMILAR COMPLAINTS, INDICATING THIS IS AN ISOLATED, SITE-SPECIFIC INCIDENT. THIS COMPLAINT WILL CONTINUE BEING MONITORED IN THE MAR COR PURIFICATION COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    THE FACILITY REPORTED 6-8 PATIENTS BECOMING SICK DURING DIALYSIS TREATMENT USING THE 23G REVERSE OSMOSIS WATER PURIFICATION SYSTEM. ALL PATIENT TREATMENTS WERE DISCONTINUED AND ONE PATIENT SOUGHT MEDICAL ATTENTION AFTER PRESENTING SYMPTOMS OF DIZZINESS AND CRAMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263563 23G SERIES REVERSE OSMOSIS SYSTEM WATER PURIFICATION SYSTEM FIP MAR COR PURIFICATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other