{ "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": "2026-10-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "NH", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "ENSCHEDE", "manufacturer_contact_address_1": "180 INTERNATIONAL DRIVE", "manufacturer_contact_pcity": "97827764", "event_type": "Injury", "report_number": "3017448360-2024-00014", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20240126", "manufacturer_address_2": "", "pma_pmn_number": "K121014", "date_of_event": "20220915", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "03801", "reporter_occupation_code": "OTHER", "manufacturer_contact_plocal": "9782776432", "noe_summarized": "1", "manufacturer_contact_l_name": "HIRTE", "source_type": [ "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "7521 PV", "date_facility_aware": "20240126", "manufacturer_g1_state": "", "reporter_country_code": "", "manufacturer_contact_area_code": "978", "date_added": "20240127", "manufacturer_contact_f_name": "THOMAS", "previous_use_code": "A", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "797602", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20240126", "brand_name": "SOLAR GI", "generic_name": "SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)", "manufacturer_d_name": "MEDICAL MEASUREMENT SYSTEMS B.V.", "manufacturer_d_address_1": "COLOSSEUM 25", "manufacturer_d_address_2": "", "manufacturer_d_city": "ENSCHEDE", "manufacturer_d_state": "", "manufacturer_d_zip_code": "7521P", "manufacturer_d_zip_code_ext": "V", "manufacturer_d_country": "NL", "manufacturer_d_postal_code": "7521PV", "device_operator": "HEALTH PROFESSIONAL", "model_number": "SOLARGI HRM H2O24P TROLLEY SYSTEM", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "FFX", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Gastrointestinal Motility (Electrical)", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1725", "device_class": "2" } } ], "product_problems": [ "Excess Flow or Over-Infusion", "Excess Flow or Over-Infusion" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "01/27/2023", "mfr_report_type": "", "manufacturer_contact_country": "US", "date_changed": "20250819", "health_professional": "N", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "PV", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "9782", "patient": [ { "patient_sequence_number": "1", "date_received": "20240126", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Life Threatening" ], "patient_age": "6 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "Non Hispanic", "patient_race": "", "patient_problems": [ "Convulsion/Seizure", "Convulsion/Seizure" ] } ], "distributor_city": "", "date_report": "20240405", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "NL", "manufacturer_contact_city": "PORTSMOUTH", "mdr_report_key": "18592284", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230127", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Notification" ], "manufacturer_g1_zip_code": "7521", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "MEDICAL MEASUREMENT SYSTEMS B.V.", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "341472564", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTION INFORMATION: THE WARNING WAS ADDED AS A RESULT OF COMMUNICATION WITH THE US FDA AS PART OF A REQUEST FOR ADDITIONAL INFORMATION ON A USFDA REPORTABLE ADVERSE EVENT THAT TOOK PLACE IN 2022. THE POTENTIAL FOR PATIENT WATER INTOXICATION IS REMOTE (ONE REPORTED CASE IN >1,000,000 PROCEDURES), HOWEVER THERE IS AN INCREASED RISK RELATED TO WATER INGRESS INTO THE PUMP. IT IS IMPORTANT TO BE AWARE OF THE RISK AND THE WAYS TO MITIGATE THIS RISK. LETTERS WERE SENT TO THE US CUSTOMERS, HOWEVER THIS WAS HANDLED/REPORTED THROUGH THE ADVERSE EVENT AND NOT THROUGH THE \"RECALL\" DEPARTMENT IN THE AGENCY. INFORMATION REGARDING A ONE-WAY VALVE WAS INADVERTENTLY COMMUNICATED WITHIN THE FIRST FOLLOW-UP REPORT AND SHOULD BE OMITTED." }, { "mdr_text_key": "341472565", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THERE WAS A PATIENT IMPACT (WATER INTOXICATION & SEIZURE) AND THERE IS A FORMAL REVIEW PROCESS BEING CONDUCTED BY THE HOSPITAL. STUDY COMMENCED AT 13:40 ON (B)(6) 2022. THEY HAD A 6YO FEMALE PATIENT WHO HAD A DROP IN THEIR SODIUM LEVELS FROM 138 MMOL/L (MEASURED PRIOR TO STUDY) TO 125MMOL/L (APPROX. 08:00 THE FOLLOWING MORNING). ACCORDING TO THE REPORT FROM THE DOCTOR, THE PATIENT DEVELOPED A SEIZURE FROM IATROGENIC HYPONATREMIA - WATER INTOXICATION. THE REMAINDER OF THE TEST WAS THEN ABORTED IMMEDIATELY AFTERWARDS (08:45 THE FOLLOWING MORNING). OUR CUSTOMER HAS INDICATED THAT THERE WERE NO LONG TERM EFFECTS TO THE PATIENT THAT THEY ARE AWARE OF, HOWEVER THE INCIDENT IS UNDER REVIEW IN THE HOSPITAL AND A FORMAL INCIDENT REPORT IS BEING PREPARED." }, { "mdr_text_key": "333895352", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THERE WAS A PATIENT IMPACT (WATER INTOXICATION & SEIZURE) AND THERE IS A FORMAL REVIEW PROCESS BEING CONDUCTED BY THE HOSPITAL. STUDY COMMENCED AT 13:40 ON (B)(6) 2022. THEY HAD A 6YO FEMALE PATIENT WHO HAD A DROP IN THEIR SODIUM LEVELS FROM 138 MMOL/L (MEASURED PRIOR TO STUDY) TO 125MMOL/L (APPROX. 08:00 THE FOLLOWING MORNING). ACCORDING TO THE REPORT FROM THE DOCTOR, THE PATIENT DEVELOPED A SEIZURE FROM IATROGENIC HYPONATREMIA - WATER INTOXICATION. THE REMAINDER OF THE TEST WAS THEN ABORTED IMMEDIATELY AFTERWARDS (08:45 THE FOLLOWING MORNING). OUR CUSTOMER HAS INDICATED THAT THERE WERE NO LONG TERM EFFECTS TO THE PATIENT THAT THEY ARE AWARE OF, HOWEVER THE INCIDENT IS UNDER REVIEW IN THE HOSPITAL AND A FORMAL INCIDENT REPORT IS BEING PREPARED." }, { "mdr_text_key": "333895353", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTION INFORMATION: [1] MODEL NUMBERS: G3-6, G3-7, G3-8, G3-12, G-14 [2] WARNINGS: THIS WARNING WAS ADDED TO THE INSTRUCTIONS FOR USE: ¿WARNING: WATER INGRESS IN THE AIR COMPRESSOR CAN CAUSE INACCURATE PRESSURE READINGS, RESULTING IN EXCESS FLUID BEING ADMINISTERED TO THE PATIENT THAN WHAT IS INDICATED BY THE SYSTEM. EXCESS FLUID CAN LEAD TO PATIENT WATER INTOXICATION, WHICH MAY CAUSE COMPLICATIONS SUCH AS SEIZURE.¿ [3] MITIGATION METHODS: AFFECTED US CUSTOMERS/CONSIGNEES WERE NOTIFIED OF THE ISSUE BY LETTER. THE COMMUNICATION IS TO MAKE THEM AWARE OF THE WARNING BEING ADDED TO THE INSTRUCTIONS FOR USE AND THE WAYS THAT CAN MITIGATE THE RISK (I.E., ENSURING THAT THEIR PUMP IS WORKING PROPERLY, AND THE INFUSION ISN¿T OCCURRING FASTER THAN EXPECTED). THE SYSTEMS HAVE BEEN IN THE MARKET FOR SEVERAL YEARS AND THE RISKS ASSOCIATED WITH PERFUSION ARE WELL KNOWN. THE INSTRUCTION MANUAL PROVIDES CLEAR INSTRUCTIONS TO THE USER FOR ENSURING THAT THE SYSTEMS ARE IN PROPER WORKING ORDER. LETTERS WERE SENT TO `US CUSTOMERS AT THE RECOMMENDATION OF USFDA. THE POTENTIAL FOR PATIENT WATER INTOXICATION IS REMOTE (ONE REPORTED CASE IN >1,000,000 PROCEDURES), HOWEVER THERE IS AN INCREASED RISK RELATED TO WATER INGRESS INTO THE PUMP. IT IS IMPORTANT TO BE AWARE OF THE RISK AND THE WAYS TO MITIGATE THIS RISK. TO ENSURE THAT YOUR DEVICE CONTINUES TO WORK SAFELY AND EFFECTIVELY, IT IS IMPORTANT THAT WATER IS NOT ALLOWED TO FLOW INTO THE PUMP AS WATER INGRESS CAN DAMAGE THE AIR COMPRESSOR. TO MITIGATE THE RISK OF WATER INGRESS NEVER HOLD THE WATER CONTAINER UPSIDE DOWN (AS STATED IN THE USER¿S MANUAL). IN SYSTEMS MANUFACTURED AFTER (B)(6) 2022 A ONE-WAY VALVE WAS ADDED TO THE TOP OF THE WATER CONTAINER, WHICH PREVENTS WATER FROM FLOWING FROM THE WATER CONTAINER TO THE PUMP AND HELPS TO PREVENT DAMAGE TO THE AIR COMPRESSOR. PRIOR TO USE IT IS IMPORTANT TO VERIFY THAT THE PUMP IS IN THE PROPER WORKING ORDER AND THAT THE PERFUSION PRESSURE EQUALS THE PRESSURE AS SET IN THE INVESTIGATION PROTOCOL IN THE SYSTEM. IN ADDITION TO VERIFYING PROPER PUMP PRESSURE, IT IS ALSO RECOMMENDED THAT YOU MONITOR THE AMOUNT OF WATER BEING PERFUSED INTO THE PATIENT BY VISUALLY OBSERVING THE LEVEL IN THE WATER CONTAINER. IF THE WATER LEVEL IN THE CONTAINER IS DECREASING FASTER THAN EXPECTED, PLEASE STOP THE PROCEDURE AND VERIFY PROPER FUNCTION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "COLOSSEUM 25", "distributor_zip_code": "", "manufacturer_contact_postal_code": "03801", "manufacturer_contact_exchange": "978", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/05/2024" } ] }