{ "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": "2026-06-30", "results": { "skip": 0, "limit": 1, "total": 18 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "NO INFORMATION", "report_to_fda": "I", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "N", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "MW5098210", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20201204", "manufacturer_address_2": "", "pma_pmn_number": "", "date_of_event": "20201123", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "RISK MANAGER", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20201207", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1415195", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20201204", "brand_name": "BAXTER SIGMA SPECTRUM INFUSION PUMP", "generic_name": "INFUSION PUMP", "manufacturer_d_name": "BAXTER HEALTHCARE CORPORATION", "manufacturer_d_address_1": "", "manufacturer_d_address_2": "", "manufacturer_d_city": "MEDINA", "manufacturer_d_state": "NY", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "35700", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20201124", "device_report_product_code": "FRN", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Pump, Infusion", "medical_specialty_description": "General Hospital", "regulation_number": "880.5725", "device_class": "2" } } ], "product_problems": [ "Fluid/Blood Leak", "Improper Flow or Infusion", "Fluid/Blood Leak", "Improper Flow or Infusion" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250729", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20201204", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "93", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20201202", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10958251", "removal_correction_number": "", "number_devices_in_event": "", "manufacturer_name": "", "report_source_code": "Voluntary report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "220180172", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "INCIDENT OCCURRED ON (B)(6) 2020 IN CCU AT APPROXIMATELY 14:20. INFUSION PUMP DATA INDICATES THAT THE DRUG HEPARIN WITH 25000 UNITS/500 ML WAS SELECTED WITH A DOSE UNIT/HR OF 900, RATE ML/HR 18. STAFF STATED THAT AFTER A SHORT TIME, THE PUMP BEGAN TO ALARM \"BAG EMPTY.\" IT APPEARED THE ENTIRE 500 ML BAG HAD INFUSED WHILE THE IV PUMP INDICATED THAT ONLY 28.5 ML HAD BEEN INFUSED. ON (B)(6) 2020 PUMP RECEIVED BY BIOMED FOR TESTING. HE COULD TELL IMMEDIATELY THAT THERE WAS SOMETHING WRONG WITH THE IV PUMP, AS SOON AS HE INSERTED THE TUBING INTO THE PUMP, CLOSED THE DOOR AND REMOVED THE KEYHOLE CLAMP, FLUID STARTED DRIPPING FROM THE END OF THE LINE. THE CLOSED DOOR ON THE PUMP SHOULD HAVE STOPPED AND CONTROLLED THE FLOW. AFTER ATTEMPTING TO VERIFY A 40 ML INFUSION, THE PUMP DELIVERED APPROXIMATELY 60 ML. BIOMED VERIFIED THAT THE PUMP HAD INDEED BEEN REMEDIATED FROM THE RECALL IN 2018 INVOLVING CAM GEAR LUBRICATION, AS WELL AS RECEIVING A PM IN (B)(6) OF 2020 TO VERIFY PROPER FUNCTIONS AND ACCURACY. IV PUMP SENT TO MANUFACTURER FOR FURTHER INVESTIGATION. PTT RETURNED TO NORMAL WITHIN 24 HOURS - NO ADVERSE EFFECTS ON PATIENT. FDA SAFETY REPORT ID# (B)(4)." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }