INSPIRE 8
Report
- Report Number
- 1718850-2025-10007
- Event Type
- Death
- Date Received
- September 22, 2025
- Date of Event
- August 25, 2025
- Report Date
- September 22, 2025
- Manufacturer
- SORIN GROUP ITALIA
- Product Code
- DTZ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
A.1.-A.5. NO PATIENT INFORMATION HAS BEEN PROVIDED. D.4. THE INSPIRE 8 OXYGENATOR AND RESERVOIR ARE A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS (B)(4). G.5. THE INVOLVED INSPIRE 8M HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STANDALONE OXYGENATOR (CATALOG NUMBER 050714) IS ALSO REGISTERED IN THE USA (510(K) NUMBER: K130433). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. H.11. LIVANOVA MANUFACTURES THE INSPIRE 8 OXYGENATOR AND RESERVOIR. BASED ON VIDEO PROVIDED BY THE CUSTOMER, THE FILTER OF THE RESERVOIR WAS FILLED TO THE TOP WITH CLOTTED BLOOD. PUMP SHEET OF THE CASE WAS RECEIVED AND ANALYZED: THE 0 ARTERIAL FLOW CONDITION STARTED AT 14,43 AND LASTED ABOUT 10 MINUTES BUT NO DETAIL OF THE SURGICAL PHASE COULD BE RETRIEVED. THROUGH FOLLOW UP LIVANOVA WAS INFORMED THAT THE PATIENT HAS CHRONIC LYMPHOCYTIC LEUKEMIA AND PATIENT HAD PLATELET COUNT OF 811 K BEFORE THE PROCEDURE AND 219K AFTER PROCEDURE. THE 219 WAS ACTUALLY WITH THE INFUSION OF 2 PACKS OF PLATELETS ACCORDING TO THE REVIEW OF THE RECEIVED INFORMATION, IT EMERGED THAT THE FIRST CIRCUIT WAS CHANGED OUT BECAUSE OF THE CLOTTING OF THE RESERVOIR FILTER ELEMENTS INDUCED BY THE CHRONIC DISEASE OF THE PATIENT (CLL AND SOCK PLATELETS) THAT ULTIMATELY DETERMINED A SPIKE OF THE LINE PRESSURE AND THE BLOCKAGE OF BLOOD FLOW. THE HIGH-PRESSURE VALUE WAS NOT QUANTIFIED, NOR THE SURGICAL STAGE WHEN THE SYSTEM WAS REPLACED AND ITS TIME DURATION WERE SPECIFIED. ACCORDING TO THE CHIEF OF THE HOSPITAL THE FAILURE OF THE CIRCUIT DURING BYPASS WAS DIRECTLY RELATED TO THE PATIENT¿S CONDITION AND MEDICAL HISTORY PRIOR TO SURGERY. THIS PATIENT HAD CHRONIC LYMPHOCYTIC LEUKEMIA AND HAD A BASELINE PLATELET COUNT OF OVER 800K. BEFORE INITIATING CARDIOPULMONARY BYPASS, SHE WAS GIVEN A FULL DOSE OF HEPARIN AT 3 MG/KG. THE ACT BEFORE BYPASS WAS OVER 700 SECONDS. AFTER ABOUT TWO MINUTES INTO THE BYPASS, A HIGH ARTERIAL LINE PRESSURE AND ANOMALOUS BLOOD FLOW INSIDE THE RESERVOIR WERE OBSERVED: BLOOD WAS COMING OUT FROM THE UPPER PORTION OF THE FILTER SOCK AT RANDOM PLACES. THE WHOLE SOCK WAS FULL OF BLOOD. AS COUNTERMEASURE, THE NEGATIVE PRESSURE IN THE RESERVOIR WAS INCREASED WITHOUT SUCCESS. SIMULTANEOUSLY, TO OPTIMIZE AND MAINTAIN AN ADEQUATE ARTERIAL FLOW, MEDICAL TEAM QUICKLY CHECKED THE FIELD FOR ANY KINKS ON THE ARTERIAL LINE AND NO OBSTRUCTION WAS FOUND, SO THE SURGEON DECIDED TO PROCEED WITH THE CROSS CLAMP. AFTER THE CLAMP WAS PLACED ON THE AORTA, WE TURNED UP THE ARTERIAL FLOW, AND AT THIS POINT THE HIGH LINE PRESSURE ALARM WAS CONSTANTLY ALARMING AND THE CARDIOPLEGIA ROLLER HEAD COULD NOT BE RUN (SAFETY FEATURE OF THE PUMP). THE CROSS CLAMP WAS REMOVED, AND THE FOCUS WAS SHIFTED AROUND THE AORTIC CANNULATION SITE LOOKING FOR A POSSIBLE AORTIC DISSECTION AND THE AORTA WAS FOUND INTACT VIA TEE. 10K UNITS OF HEPARIN WERE ADDED IN THE CIRCUIT TO MANAGE THE CLOT FORMATION. THIS WHOLE SEQUENCE OF EVENTS HAPPENED IN NO MORE THAN 10 MINUTES. EVENTUALLY, IT WAS AGREED TO NO LONGER CONTINUE BYPASS WITH THAT CIRCUIT AND TO COME OFF PUMP. THE CHANGE OUT WAS CONDUCTED WITH THE PATIENT¿S HEART BEATING ON ITS OWN, ANESTHESIA VENTILATING, AND ALSO VOLUME RESUSCITATED WITH 2 UNITS OF RED CELLS. FULL BYPASS WAS RESUMED IN NO MORE THAN 15 SECONDS. INITIATION OF BYPASS THE SECOND TIME WAS SMOOTH, AND THERE WERE NO MORE DIFFICULTIES OBSERVED DURING THIS BYPASS RUN. TWO UNITS OF PLATELETS WERE ORDERED BY THE SURGEON IN THE OPERATING ROOM BEFORE CLOSING THE CHEST, AS THE PATIENT WAS OOZY AFTER PROTAMINE. THE PLATELET COUNT OF 219K WAS DONE POST OP IN THE ICU. SURGERY WAS DONE IN THE MORNING OF (B)(6)). CT SCAN WAS DONE 48 HOURS POST OP AND WAS NEGATIVE FOR STROKE. AN EEG WAS PERFORMED ON (B)(6), AND THERE WERE BRAIN ACTIVITIES ACCORDING TO ONE OF THE ICU NURSES. PATIENT WAS BREATHING EVEN THOUGH IF INTUBATED AND VENTILATED. DESPITE ALL THESE POSITIVE SIGNS, THE PATIENT NEVER WOKE UP. ON SATURDAY, (B)(6), PATIENT WAS PLACED ON COMFORT MEASURES AND DIED THE SAME DAY. A MEDICAL ASSESSMENT WAS HELD WITH LIVANOVA CLINICAL EXPERTS, WHO CONFIRMED THAT THE MALFUNCTION LINKED TO THE INSPIRE OXYGENATOR (CLOGGED RESERVOIR FILTER AND HIGH ARTERIAL LINE PRESSURE WITH IMPOSSIBILITY TO ACHIEVE ADEQUATE FLOW) WAS CAUSED BY THE PROCEDURE COMBINED WITH THE PATIENT CONDITIONS ONLY. THE EVENT IS NOT DEVICE-RELATED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
SORIN GROUP ITALIA RECEIVED A REPORT THAT, SHORTLY AFTER GOING ON BYPASS, MEDICAL TEAM COULD NOT GET ANY FLOW THROUGH THE RESERVOIR OF THE INSPIRE 8 OXYGENATOR. MEDICAL TEAM REPORTED THAT THEY HAD HIGH LINE PRESSURE, ACT WAS OVER 700 AND THE FILTER MAY GOT BLOCKED, THEN TEAM ELECTED TO CHANGE OUT THE OXYGENATOR AROUND 10 MINUTES AFTER GOING ON BYPASS. THROUGH FOLLOW UP LIVANOVA WAS INFORMED THAT, AS OF (B)(6), THE PATIENT HAD NOT WOKEN UP. PROCEDURE WAS DONE ON (B)(6) 2025. THE PATIENT NEVER WOKE UP AFTER PROCEDURE. ON (B)(6) 2025, PATIENT WAS PLACED ON COMFORT MEASURES AND DIED ON THE SAME DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1960652 | INSPIRE 8 | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | SORIN GROUP ITALIA | INSPIRE 8 M N/S |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |