{ "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": "2026-09-29", "results": { "skip": 0, "limit": 1, "total": 17067 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "BDX", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SAN DIEGO", "manufacturer_contact_address_1": "3750 TORREY VIEW CT", "manufacturer_contact_pcity": "85861720", "event_type": "Malfunction", "report_number": "2016493-2026-33545", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260603", "manufacturer_address_2": "", "pma_pmn_number": "EXEMPT", "date_of_event": "20260505", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "92130", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "8586172000", "noe_summarized": "1", "manufacturer_contact_l_name": "WILKO", "source_type": [ "Health Professional", "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "921214386", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260603", "manufacturer_contact_f_name": "BRETT", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1432290", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20260603", "brand_name": "BD PYXIS¿ MEDSTATION¿ ES", "generic_name": "AUTOMATED DISPENSING CABINET", "manufacturer_d_name": "CAREFUSION 303, INC.", "manufacturer_d_address_1": "3750 TORREY VIEW CT", "manufacturer_d_address_2": "", "manufacturer_d_city": "SAN DIEGO", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "92130", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "92130", "device_operator": "OTHER", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "BRY", "device_age_text": "", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Cabinet, Table And Tray, Anesthesia", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.6100", "device_class": "1" } } ], "product_problems": [ "Electrical /Electronic Property Problem", "Application Program Problem" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260615", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "4386", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260603", "sequence_number_treatment": [ "S/N: (B)(6), LOCATION: ZZGW1HTES." ], "sequence_number_outcome": [ "" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260520", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SAN DIEGO", "mdr_report_key": "25369975", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260505", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "92121", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "CAREFUSION SD", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "404513782", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "D.4 & H.4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER, AND MANUFACTURER DATE NOT AVAILABLE. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINT(S) WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 05-AUG-2010 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE REMOTE MANAGER HAD FAILED. A FIELD SERVICE ENGINEER (FSE) INSTRUCTED THE CUSTOMER TO RECOVER THE REMOTE MANAGER AND VERIFIED FUNCTIONALITY USING TEST SOFTWARE, WITH NO ERROR REPRODUCIBLE AT THAT TIME. FURTHER INSPECTION IDENTIFIED THAT THE LATCH MICROSWITCH CONTACTS WERE SEVERELY CORRODED, AND THE LATCH DETENT WAS REPLACED. THE REMOTE MANAGER WAS TESTED AGAIN USING DIAGNOSTIC SOFTWARE, AND RECOVERY OF THE LATCH WAS PERFORMED. ALL FUNCTIONS WERE VERIFIED TO BE OPERATING NORMALLY. THE SYSTEM FUNCTIONED AS INTENDED AFTER FIELD SERVICE ENGINEER REPAIRED THE DEVICE." }, { "mdr_text_key": "404513783", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES REMOTE MANAGER FAILED. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION WHICH CAUSED A DELAY TO THE PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "10020 PACIFIC MESA BLVD", "distributor_zip_code": "", "manufacturer_contact_postal_code": "92130", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }