INSPIRE 8F M
Report
- Report Number
- 9680841-2022-00059
- Event Type
- Malfunction
- Date Received
- December 6, 2022
- Report Date
- December 2, 2024
- Manufacturer
- SORIN GROUP ITALIA SRL
- Product Code
- DTZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE COMPLAINED INSPIRE 8F OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (CATALOGUE IN00589) THAT IS NOT DISTRIBUTED IN THE USA. 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. THE COMPLAINED INSPIRE 8F OXYGENATOR IS SIMILAR TO THE INSPIRE 8F OXYGENATOR CATALOGUE 050703, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS 08033178112284. THE COMPLAINED INSPIRE 8F OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA AND SIMILAR TO THE INSPIRE 8F CATALOGUE 050703, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K180448). THE DEVICE MANUFACTURING DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 8F. THE INCIDENT OCCURRED IN BARCELONA, SPAIN. LIVANOVA IS FOLLOWING UP WITH THE CUSTOMER FOR ADDITIONAL INFORMATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
BASED ON MANUFACTURING RECORDS, TWO POSSIBLE LOTS OF OXYGENATOR 03705PTS WERE ASSEMBLED IN THE INVOLVED PTS LOT, WHICH ARE THE FOLLOWING: 2205110073 AND 2205100087. MANUFACTURING RECORDS HAVE BEEN VERIFIED TO BE CONFORMING TO SPECIFICATIONS. NO OTHER SIMILAR EVENTS HAVE BEEN IDENTIFIED FOR THIS PTS PN OR LOT AND FOR BOTH OXYGENATOR LOTS. DESPITE BEING REQUESTED, THE ITEM WAS NOT RETURNED FOR INVESTIGATION. NO PICTURES OR INFORMATION REGARDING THE PRECISE LEAK LOCATION WERE PROVIDED. BASED ON AVAILABLE INFORMATION AND CONSIDERING SIMILAR COMPLAINT INVESTIGATIONS, IT CANNOT BE EXCLUDED THAT THE REPORTED EVENT WAS DUE TO A OPEN CHANNEL BETWEEN BLOOD AND WATER COMPARTMENTS DUE TO DAMAGED CAPILLARY IN THE DISTAL PORTION OF HEAT EXCHANGER FIBERS. CONSIDERING THAT 100% OF THE UNITS IN PRODUCTION LINE IS SUBJECTED TO FINAL LEAK TEST AND THAT INVOLVED UNIT SUCCESSFULLY PASSED THE IN-PROCESS CHECK AND NO TREND HAS BEEN REGISTERED FOR SIMILAR CASE, IT CANNOT BE EXCLUDED THAT FIBER BUNDLE CAPILLARY MANUFACTURING VARIABILITY WITH CONTRIBUTION OF STERILIZATION THERMAL AND/OR TRANSPORTATION MECHANICAL STRESS COULD HAVE LED TO BREAKAGE DURING USE. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.
H 11: THE INVOLVED OXYGENATOR WAS RETURNED TO SORIN GROUP ITALY FOR INVESTIGATION. THE UNIT WAS VISUALLY INSPECTED AND NO VISIBLE SIGN OF DAMAGE TO FIBER BUNDLE CAPILLARY OF HEAT EXCHANGER MODULE WAS DETECTED. A SUBSEQUENT FUNCTIONAL TEST WAS PERFORMED TO VERIFY THE INTEGRITY OF THE WATER COMPARTMENT. THE UNIT WAS SUBJECTED TO AIR LEAK TEST BY SETTING THE SAME PARAMETERS APPLIED DURING THE IN-PROCESS LEAK TEST WHICH IS PERFORMED ON 100% OF THE UNITS IN MANUFACTURING LINE. SPECIFICALLY, THE WATER COMPARTMENT WAS PRESSURIZED TO 3 BAR (FILLING STEP AND STABILIZATION STEP) AND THE ENTITY OF THE PRESSURE DROP WAS MEASURED IN THE FINAL LEAK STEP. AS PER MANUFACTURING PROCESS SPECIFICATIONS, LEAK TEST FAILS IF THE PRESSURE DROP VALUE IS ABOVE 4.9 MBAR (REJECT LIMIT). ACCORDING TO TEST RESULTS, COMPLAINED UNIT SUCCESSFULLY PASSED THE LEAK TEST SINCE THE PRESSURE DROP REGISTERED WAS 2.6 MBAR, WITHIN ACCEPTABLE LIMITS. TAKING INTO ACCOUNT THE COLLECTED EVIDENCE, NO LOSS OF HEAT EXCHANGER FIBERS INTEGRITY WAS CONFIRMED. THEREFORE, IT CANNOT BE RULED OUT THAT OBSERVED GENERATION OF WATER MAY BE CORRELATED WITH CONDENSATION EVENT DEVELOPED AT CUSTOMER SITE, DUE TO THE POSSIBILITY OF WATER MOLECULES TO PASS THROUGH THE OXYGENATOR FIBERS DEPENDING ON TEMPERATURE DIFFERENCE BETWEEN WATER SIDE AND BLOOD SIDE (I.E. WHEN WARM WATER IS CIRCULATING INSIDE THE INSPIRE HEAT EXCHANGER AND ITS TEMPERATURE IS MARKEDLY DIVERGING IN RESPECT TO INNER PLASTIC SURFACES TEMPERATURE). THE OBSERVED WATER VAPOR CONDENSATION, HOWEVER, DOES NOT AFFECT PERFORMANCE OR STERILITY OF INSPIRE. ONCE THE BLOOD SIDE IS PRIMED, THE SMALL AMOUNT OF CONDENSED WATER IS ABSORBED INTO THE PRIME. BASED ON THE INVESTIGATION RESULTS, THE EVENT HAS BEEN RE-ASSESSED AS NOT REPORTABLE, SINCE THE ISSUE (OXYGENATOR LEAK) IS NOT A MALFUNCTION THAT MIGHT CAUSE ANY PATIENT INJURY.
SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, WHEN ASSEMBLING THE CIRCUIT FOR THE PROCEDURE, BEFORE PRIMING, THE MEDICAL TEAM OBSERVED LEAKAGE FROM THE CONNECTIONS OF THE NORMO-HYPOTHERMIA HOSES TO THE OXYGENATOR MODULE. THERE WAS NO PATIENT INVOLVEMENT.
SEE INTIAL REPORT.
SEE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2053287 | INSPIRE 8F M | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | SORIN GROUP ITALIA SRL | 03705PTS | 2205100087 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |