{ "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": { "skip": 0, "limit": 1, "total": 169505 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "8010762-2020-00139", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K991864", "date_of_event": "20200417", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "CONSUMER", "FOREIGN", "HEALTH PROFE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "SZ", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "463533", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "HEART LUNG MACHINE", "generic_name": "PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE", "manufacturer_d_name": "MAQUET CARDIOPULMONARY GMBH", "manufacturer_d_address_1": "NEUE ROTTENBURGER STRASSE 37", "manufacturer_d_address_2": "", "manufacturer_d_city": "HECHINGEN", "manufacturer_d_state": "", "manufacturer_d_zip_code": "", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "", "device_operator": "HEALTH PROFESSIONAL", "model_number": "701022161 - ROTAFLOW DRIVE UNIT, BLUE", "catalog_number": "701022161", "lot_number": "", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200701", "device_report_product_code": "KFM", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "8010762" ], "fei_number": [ "3009649876" ], "device_name": "Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4360", "device_class": "2" } } ], "product_problems": [ "Pumping Stopped", "Pumping Stopped" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/28/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250731", "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": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "68 YR", "patient_sex": "", "patient_weight": "75", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Consequences Or Impact To Patient", "No Consequences Or Impact To Patient" ] } ], "distributor_city": "", "date_report": "20200901", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000399", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200420", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "320113027", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "COMPLAINT ID: (B)(4)." }, { "mdr_text_key": "320113028", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE INITIAL FAILURE DESCRIPTION WAS \"HEAD ERROR\". ACCORDING TO SERVICE ORDER (B)(4) DATED ON (B)(6) 2020 A GETINGE SERVICE TECHNICIAN COULD NOT DUPLICATE THE ERROR MESSAGE \"HEAD ERROR\". THE DEVICE IN QUESTION HAS BEEN SUBJECTED TO AN INTENSIVE FUNCTIONAL TEST. THE CONNECTIONS CABLE OF THE ROTAFLOW DRIVE HAS BEEN MOVED IN ALL DIRECTIONS. THE \"HEAD ERROR\" COULD NOT BE REPRODUCED THIS WAY. THE DEVICE WORKS FAULTLESSLY. 2020-07-01: THE CONCERNED DRIVE WAS RECEIVED FOR FURTHER INVESTIGATIONS BY MAQUET UNDER RMA#41098. 2020-07-07: THE FAILURE \"HEAD ERROR\" COULD NOT BE CONFIRMED IN THE SERVICE DEPARTMENT. 2020-07-31: DRIVE WAS SEND TO THE SUPPLIER EM-TEC FOR FURTHER INVESTIGATION. 2020-08-27: THE FAILURE \"HEAD ERROR\" COULD NOT BE CONFIRMED BY THE SUPPLIER EM-TEC. ACCORDING TO THE SERVICE REPORT RMA2020-10243 DATED ON 2020-08-27 THE ROTAFLOW DRIVE WAS INVESTIGATED AND FOLLOWING DIAGNOSIS WAS PROVIDED: THE HEAD ERROR COULD NOT BE CONFIRMED. THE YELLOW DOT ON THE PUMP FITTING IS MISSING. MAST HOLDER HAS A GAP ON THE SCREWING OF THE JOINT. THE FRONT EDGE OF THE FLOW SENSOR IS BROKEN. STRONG VIBRATIONS DURING USE. IRON RING ON THE MAGNETIC COUPLING HAS BEEN DETACHED. FOLLOWING ACTIONS TO REPAIR THE DRIVE HAVE BEEN TAKEN. THE YELLOW DOT AND RUBBER BURL HAVE BEEN MOUNTED. THE MAGNETIC COUPLING HAS BEEN REPLACED. THE FINAL TEST FOR THE PRODUCT STATUS REPORT HAS BEEN PASSED. MOST POSSIBLE ROOT CAUSE COULD BE DETERMINED AS: AGING. IN ADDITION THE FOLLOWING MOST POSSIBLE ROOT CAUSE COULD BE DETERMINED FOR THE HEAD ERROR: THE HEAD ERROR FOLLOWS THE SIG ERROR. WHEN THE ULTRASONIC CREAM IS APPLIED (DUE TO THE SIG ERROR) TO THE FLOW BUBBLE SENSOR AND THE DISPOSABLE IS MOVED CLOSE TO THE ROTA FLOW DRIVE, THE MAGNETS IN THE CENTRIFUGAL PUMP INTERFERE WITH THE SENSORS IN THE ROTA FLOW DRIVE. THIS ERROR CAN BE OVERWRITTEN BY RESTARTING THE ROTA FLOW CONSOLE. IF THE RPM / LPM IS SET TO ZERO AND THE DRIVE AS WELL AS THE INSERTED CENTRIFUGAL PUMP ARE SHAKEN THIS CAUSES MAGNETIC UNCOUPLING OF THE CENTRIFUGAL PUMP AND THUS LEADS TO THE HEAD ERROR. THIS ERROR CAN BE OVERWRITTEN BY RESTARTING THE ROTA FLOW CONSOLE. FURTHERMORE, THE INSTRUCTIONS FOR USE OF THE ROTAFLOW SYSTEM, SEE ROTAFLOW INSTRUCTION FOR USE, INSTRUCTIONS FOR USE / 4.2 / EN / 13 CONTAIN DETAILED DESCRIPTIONS TO PREVENT AN ¿HEAD ERROR¿. THE REPORTED FAILURE \"HEAD ERROR\" WAS DISCOVERED DURING PATIENT TREATMENT. THE DEVICE WAS DIRECTLY INVOLVED IN THE INCIDENT. THE FAILURE COULD NOT BE CONFIRMED. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING." }, { "mdr_text_key": "195950062", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE." }, { "mdr_text_key": "195950083", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "THE ROTAFLOW WAS RUNNING AS V-A ECMO. THE DEVICE SUDDENLY INDICATED \"HEAD ERROR\". THE ANESTHETIST ON DUTY WAS CALLED TO HAND CRANK AND SWITCH THE DEVICE OFF AND BACK UP. IN 2 ATTEMPTS THERE WAS ALWAYS THE ERROR MESSAGE: \"HEAD ERROR\". THE CARDIO TECHNICIAN, WHO WAS ON SITE IN 10 MINUTES, ALSO TRIED 1-2 TIMES, ALWAYS THE SAME ERROR MESSAGE, THEN IT WAS DECIDED TO CHANGE THE DEVICE. DEVICE WAS SWITCHED AND EVERYTHING WORKED. PATIENT NOT HARMED. (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": "09/01/2020" } ] }