{ "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": 12304 } }, "results": [ { "manufacturer_contact_zip_ext": "8930", "manufacturer_g1_address_2": "SUITE 50", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MS.", "manufacturer_contact_state": "IL", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "NORTH ANDOVER", "manufacturer_contact_address_1": "3 CORPORATE DRIVE", "manufacturer_contact_pcity": "84755029", "event_type": "Malfunction", "report_number": "3014732157-2026-02678", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260603", "manufacturer_address_2": "", "pma_pmn_number": "K183311", "date_of_event": "20260508", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "60047", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "8475502913", "noe_summarized": "1", "manufacturer_contact_l_name": "MCCANDLESS", "source_type": [ "User facility" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "01845", "manufacturer_g1_state": "MA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260603", "manufacturer_contact_f_name": "REBECCA", "device_date_of_manufacturer": "20241017", "previous_use_code": "U", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1432566", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20260603", "brand_name": "IVENIX INFUSION SYSTEM", "generic_name": "LARGE VOLUME PUMP (LVP)", "manufacturer_d_name": "FRESENIUS KABI USA, LLC", "manufacturer_d_address_1": "50 HIGH STREET", "manufacturer_d_address_2": "SUITE 50", "manufacturer_d_city": "NORTH ANDOVER", "manufacturer_d_state": "MA", "manufacturer_d_zip_code": "01845", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "01845", "device_operator": "OTHER", "model_number": "LVP-0004", "catalog_number": "LVP-0004", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FRN", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "00811505030320", "udi_public": "00811505030320", "openfda": { "device_name": "Pump, Infusion", "medical_specialty_description": "General Hospital", "regulation_number": "880.5725", "device_class": "2" } } ], "product_problems": [ "No Apparent Adverse Event", "Program or Algorithm Execution Problem" ], "reporter_state_code": "MD", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260616", "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": "20260603", "sequence_number_treatment": [ "" ], "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": "20260602", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "LAKE ZURICH", "mdr_report_key": "25369460", "removal_correction_number": "3014732157-05/06/2026-00", "number_devices_in_event": "", "date_manufacturer_received": "20260508", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Recall" ], "manufacturer_g1_zip_code": "01845", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "FRESENIUS KABI USA, LLC", "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": "404622974", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE FOLLOWING HAS BEEN REPORTED: CUSTOMER REPORTED: \"UNDERSTAND THAT 69% DOESN'T MEAN IT IS IN FAILURE MODE BUT STILL VERY CONCERNING.\" FRESENIUS KABI HAS REVIEWED LOGS AND ASSESSED THE ISSUE TO BE CONSISTENT WITH A BATTERY MONITORING LOGIC SYNC ERROR. REVIEW OF DEVICE LOGS SHOWS THAT THE HEALTH VALUE OF 69% IS AUTOMATICALLY ASSIGNED WHEN THE BATTERY VOLTAGE READING FALLS BELOW A DEFINED MINIMUM THRESHOLD USED TO DETECT AGING BATTERIES. IN THE REPORTED CASES, THE PUMP BRIEFLY LOGGED A SINGLE LOW-VOLTAGE VALUE THAT WAS INCONSISTENT WITH SURROUNDING VOLTAGE MEASUREMENTS. THIS TRIGGERED THE HEALTH CALCULATION TO ASSIGN 69%, DESPITE THE BATTERY OTHERWISE APPEARING HEALTHY. USERS EXPECTED THE DISPLAYED BATTERY HEALTH TO REFLECT TRUE BATTERY CONDITION, BUT THE PUMP INSTEAD RESPONDED TO A TRANSIENT, ERRONEOUS READING. THE BEHAVIOR DEVIATES FROM EXPECTED FUNCTION BECAUSE THE VOLTAGE READING USED TO SET HEALTH DID NOT REPRESENT THE ACTUAL BATTERY STATE. THIS IS DUE TO A SW ANOMALY TRIGGERED BY A STATE MACHINE COMMUNICATION ERROR ON THE I2C CHIP WHICH WAS MADE VISIBLE DUE TO SW CHANGES MADE FOR SW VERSION 5.10.2 RELEASED IN NOV 2025. THE ANOMALY CAUSES THE PUMP TO REPORT BATTERY HEALTH OF 69% WHICH APPEARS IN THE BATTERY HEALTH REPORT FROM THE IMS SYSTEM. THIS ALSO TRIGGERS THE \"BATTERY EXTREMELY LOW ALARM\" FOR THE BATTERY ON THE PUMP (INDICATING 5 MINUTES OF BATTERY CHARGE REMAINING) WHICH THEN STARTS THE COUNTDOWN TIMER WHICH WILL THEN ISSUE AN ALARM AND SHUT DOWN THE PUMP AT THE 1 MINUTE MARK UNLESS THE PUMP IS PLUGGED INTO MAINS POWER. THESE WARNINGS WERE NOT BASED ON TRUE BATTERY DEPLETION BUT ON A MOMENTARY INCORRECT MEASUREMENT. NO EVIDENCE SUGGESTS A DESIGN FLAW IN BATTERY BEHAVIOR; THE ISSUE APPEARS RELATED TO TRANSIENT COMMUNICATION ERROR AFFECTING HEALTH-CALCULATION LOGIC. FRESENIUS KABI PLANS TO RESOLVE THE ISSUE IN A FUTURE SW RELEASE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "50 HIGH STREET", "distributor_zip_code": "", "manufacturer_contact_postal_code": "600478930", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }