INSPIRE 8 M START N/S
Report
- Report Number
- 9680841-2024-00016
- Event Type
- Malfunction
- Date Received
- May 10, 2024
- Date of Event
- April 11, 2024
- Report Date
- September 11, 2024
- Manufacturer
- SORIN GROUP ITALIA SRL.
- Product Code
- DTZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.11: THROUGH FOLLOW-UP COMMUNICATION, LIVANOVA LEARNED THAT THE HEART LUNG MACHINE STOPPED DUE TO THE FACT THAT THE PRESSURE THRESHOLD SET BY PERFUSIONIST WAS REACHED. CHANGE-OUT OF THE UNIT LASTED NEARLY 5 MINUTES AND IT WAS DURING AORTIC CROSS CLAMP. NO ACTION IS DEEMED NECESSARY. THE RISK IS IN THE ACCEPTABLE REGION. LIVANOVA MAINTAINS AND DOCUMENTS PERIODIC CUSTOMER EVENTS MONITORING PROCESS TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT. LIVANOVA WILL KEEP MONITORING THE MARKET.
A.1.-A.5. PATIENT INFORMATION WERE NOT PROVIDED. D.4. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED INSPIRE 8 START OXYGENATOR IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. G.5. THE COMPLAINED INSPIRE 8 START IS NOT DISTRIBUTED IN THE USA, AND IT IS SIMILAR TO THE INSPIRE 8 OXYGENATOR 050714, WHICH IS DISTRIBUTED 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. SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 8 START HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN GERMANY. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. THE RETURNED UNIT WAS VISUALLY INSPECTED AND PRESENCE OF DRIED BLOOD ALONG OXYGENATOR FIBRES WAS NOTICED. UPON COMPLETION OF CLEANING PHASE, THE OXYGENATOR WAS SUBJECTED TO FUNCTIONAL PRESSURE DROP VERIFICATION TEST WITH BOVINE BLOOD AS PER DESIGN SPECIFICATIONS (B)(4) AND UNI ISO (B)(4). LABORATORY TEST COULD NOT REPRODUCE ANY INCREASED PRESSURE DROP ACROSS THE OXYGENATOR WHICH BEHAVED AS EXPECTED WITHOUT ANY PERFORMANCE DEVIATION IDENTIFIED IN TERMS OF PRESSURE EXCURSION IN BLOOD PATH. MEASURED P IN BLOOD PATH WAS FOUND ALIGNED WITH ACCEPTABLE RANGE OF VALUES PRESCRIBED WITHIN PRODUCT SPECIFICATIONS AS PER REPORTED BLOOD PARAMETERS TEST CONDITIONS. RETURNED DEVICE DID NOT EXHIBIT ANY INCREASED HYDRAULIC RESISTANCE DURING THE TEST: FIBERS WERE FOUND PATENT AND NOT OCCLUDED. NO MANUFACTURING QUALITY ISSUE POSSIBLY LINKED WITH THE REPORTED CONDITION WAS CONFIRMED ACCORDINGLY. TAKING INTO ACCOUNT THE INVESTIGATION RESULTS, REPORTED EVENT WAS REASONABLY TRACED BACK TO UNEXPECTED AND PROGRESSIVE BUILD UP OF BIOLOGICAL DEPOSITS (PLATELET AGGREGATES AND FIBRIN MASS) INSIDE THE OXYGENATOR FIBERS, WHICH REDUCED THE OPEN SURFACE FOR BLOOD FLOW. LIVANOVA CONDUCTED A LITERATURE AND TECHNICAL ANALYSIS ABOUT THE TRANS-MEMBRANE OXYGENATOR PRESSURE GRADIENTS (CP_MIR_MIS_000682, REV 000). PRESSURE DROP EXCURSION ACROSS THE OXYGENATOR IS A KNOWN PHENOMENON REPORTED IN LITERATURE IN ALL MEMBRANE OXYGENATORS. THE MAIN CAUSE OF THE PRESSURE EXCURSION HAS BEEN IDENTIFIED IN THE PLATELET ACTIVATION AND ADHESION WITHIN THE OXYGENATOR THAT PROGRESSES TO INCREASE RESISTANCE TO BLOOD FLOW DURING CARDIOPULMONARY BYPASS. THE FACTORS INFLUENCING PRESSURE EXCURSIONS CAN BE ASSIGNED TO THREE MAIN AREAS: SURGERY CLINICAL IMPACT, CPB CLINICAL IMPACT, PATHOLOGICAL PATIENT CONDITIONS. RESEARCH ON THE PHENOMENON CONSISTENTLY CONCLUDES THAT THE PRESSURE EXCURSION IS COMPLEX AND MULTIFACTORIAL AND IN MOST OF THE CASES NONE OF THE FACTORS CONSIDERED SINGULARLY CAUSES THE PHENOMENON. AN ACCURATE ANALYSIS AND MONITORING OF THE FACTORS IDENTIFIED CAN LEAD TO THE REDUCTION OF THE PHENOMENON DURING CPB. NEVERTHELESS AT CURRENT STATE OF KNOWLEDGE THE COMPLEX NATURE OF THE PHENOMENON DOES NOT ALLOW ITS COMPLETE ELIMINATION.
D.4. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT. THE COMPLAINED INSPIRE 8 START OXYGENATOR IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. G.5. THE COMPLAINED INSPIRE 8 START IS NOT DISTRIBUTED IN THE USA, AND IT IS SIMILAR TO THE INSPIRE 8 OXYGENATOR 050714, WHICH IS DISTRIBUTED 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.10. SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 8 START HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN GERMAY. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
SEE INITIAL REPORT.
SEE INITIAL REPORT.
SORIN GROUP ITALIA HAS RECEIVED A REPORT OF A SUDDEN INCREASE IN TRANSMEMBRANE PRESSURE TO OVER 660 MMHG ACROSS THE INSPIRE OXYGENATOR. MEDICAL TEAM ELECTED TO ADMINISTER MAGNESIUM TO SOLVE THE ISSUE. AS A RESULT OF THE PRESSURE INCREASE, THE HEART-LUNG MACHINE STOPPED AND PERFUSION HAD TO BE INTERRUPTED. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 879181 | INSPIRE 8 M START N/S | OXYGENATOR, CARDIOPULMONARY BYPASS, | DTZ | SORIN GROUP ITALIA SRL. | 03703 | 2301050082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |