BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WRO 300H

    MDR report key: 6149542 · Received December 6, 2016

    Report

    Report Number
    3019131-2016-00003
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    October 31, 2016
    Report Date
    December 6, 2016
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K093608
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY REPORTED TWO PATIENTS ON (B)(6) 2016 DURING DIALYSIS EXPERIENCED SHORTNESS OF BREATH, INCREASED ARTERIAL PRESSURES AND A CHANGE IN VITALS. IT WAS OBSERVED A CARBON FILTER HAD THE END CAP COME LOOSE FROM THE BODY OF THE CARBON FILTER/BLOCK. THE RO MACHINE AND CARBON PRETREATMENT WAS PUT INTO QUARANTINE. ON (B)(6), THE QUARANTINED UNIT WAS USED ON A PATIENT THAT EXPERIENCED THE SAME SYMPTOMS. THE FACILITY REPORTS ALL PATIENTS ARE BEING MONITORED PER THEIR POLICY, FOR ONE MONTH. THE CARBON BLOCKS/FILTERS ARE A CONSUMABLE ITEM THAT ARE NOT SERVICED/REPLACED BY MAR COR AT THIS FACILITY; FACILITY EMPLOYEES PERFORM THIS FUNCTION. PER (B)(6) GUIDANCE S&C -09-01, DIALYSIS FACILITIES ARE REQUIRED TO HAVE A CARBON ADSORPTION SYSTEM CAPABLE OF REMOVING BOTH FREE CHLORINE AND CHLORAMINE TO SAFE LEVELS (SECTION V192). TWO CARBON BLOCKS/BEDS ARE REQUIRED TO BE INSTALLED IN SERIES, WITH A SAMPLE PORT INSTALLED AFTER THE FIRST BED/BLOCK AND AFTER THE SECOND BED/BLOCK (SECTION V192, ALSO AAMI RD52:2004 SECTION 5.2.5). THIS WILL ALLOW A MARGIN OF SAFETY IF THE FIRST/PRIMARY CARBON BED BECOMES EXHAUSTED, ESSENTIALLY THE FULL CAPACITY OF THE SECOND BED REMAINS AVAILABLE FOR PROTECTION AGAINST CHLORINE/CHLORAMINE BREAKTHROUGH (SECTION V196 AND RD52 6.2.5). RESULTS FOR CHLORINE /CHLORAMINE TESTING WERE NOT PROVIDED TO MAR COR, BUT ARE REQUIRED AT THE BEGINNING OF EACH TREATMENT DAY AND ALSO PRIOR TO EACH PATIENT SHIFT, WITH TESTING AT EVERY 4 HOURS IF PATIENT SHIFTS HAVE NOT BEEN DEFINED. IT IS UNKNOWN IF THIS FACILITY IS FOLLOWING THE RECOMMENDATIONS AND GUIDELINES. A REQUEST WAS MADE, BUT THE DEVICE HAS NOT BEEN RETURNED TO MAR COR. THIS COMPLAINT WILL CONTINUE TO BE MONITORED THROUGH THE MAR COR COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    THE FACILITY REPORTED THREE (3) DIALYSIS PATIENTS EXPERIENCED SYMPTOMS OF SHORTNESS OF BREATH, INCREASED ARTERIAL PRESSURE AND A CHANGE IN VITALS DURING DIALYSIS. THE FACILITY SUSPECTS CHLORINE BREAKTHROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800004 WRO 300H WATER PURIFICATION SYSTEM FOR HEMODIALYSIS FIP MAR COR PURIFICATION 107365

    Patients

    Seq Age Sex Outcome Treatment
    1 Other