{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-07",
    "results": {
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          "openfda": {
            "device_name": "Dialyzer, High Permeability With Or Without Sealed Dialysate System",
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            "regulation_number": "876.5860",
            "device_class": "2"
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      "reporter_state_code": "DC",
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250813",
      "health_professional": "",
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      "manufacturer_contact_extension": "",
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      "patient": [
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          "date_received": "19920722",
          "sequence_number_treatment": [
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          "sequence_number_outcome": [
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          ],
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          "patient_sex": "",
          "patient_weight": "",
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          "patient_race": ""
        }
      ],
      "distributor_city": "",
      "date_report": "19920708",
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      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "date_report_to_manufacturer": "19920708",
      "manufacturer_contact_city": "",
      "mdr_report_key": "1000",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_report_to_fda": "19920708",
      "manufacturer_name": "",
      "report_source_code": "Distributor report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "614",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "PATIENT STARTED ON HEMODIALYSIS ALARMS INTACT.  MACHINE ALARMED, TESTED FOR BLOOD IN DIALYSATE POSITIVE.  HEMODIALYSIS STOPPED NO BLOOD RETURNED TO PATIENT PER HCP.  EBL 250CC PER HCPDEVICE LABELED FOR SINGLE USE.  PATIENT MEDICAL STATUS PRIOR TO EVENT:  INVALID DATA.  THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE.  NO DATA - REGARDING DATE LAST SERVICED.  SERVICE PROVIDED BY:  INVALID DATA.  INVALID DATA - SERVICE RECORDS AVAILABILITY.  NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED.  DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT.  METHOD OF EVALUATION:  NO DATA.  RESULTS OF EVALUATION:  NO DATA.  CONCLUSION:  NO DATA.  CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT:  INVALID DATA.  CORRECTIVE ACTIONS:  NO DATA.  THE DEVICE WAS DESTROYED/DISPOSED OF."
        }
      ],
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      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}