INSPIRE 6F DUAL HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VEN/CARD RES
Report
- Report Number
- 9680841-2018-00028
- Event Type
- Malfunction
- Date Received
- October 24, 2018
- Date of Event
- September 6, 2018
- Report Date
- December 5, 2018
- Manufacturer
- SORIN GROUP ITALIA SRL
- Product Code
- DTZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PATIENT INFORMATION WAS NOT PROVIDED THE INSPIRE 6F DUAL HOLLOW FIBER OXYGENATOR IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (LOT 1804160162) 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 AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF EVENT. (B)(4). THE COMPLAINED INSPIRE 6F HOLLOW FIBER OXYGENATOR IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050715) IS REGISTERED IN THE USA (510(K) NUMBER: K130209). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT YET RETURNED FROM DECONTAMINATION.
SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6F M HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN BAD BEVENSEN, GERMANY. PER EXEMPTION NUMBER E2016005, SORIN GROUP ITALIA S.R.L. IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP ITALIA S.R.L (MANUFACTURER) AND LIVANOVA USA., INC. (IMPORTER). THE INVOLVED DEVICE WAS RETURNED TO SORIN GROUP ITALIA FOR INVESTIGATION. VISUAL INSPECTION OF THE DEVICE DID NOT IDENTIFY ANY VISIBLE DEFECT. TO EVALUATE THE PRESSURE DROP UNDER STANDARD CONDITIONS, SIMULATED USE TESTING WAS PERFORMED. NO DEVICE MALFUNCTION WAS IDENTIFIED DURING THIS TESTING. THE DEVICE WAS FOUND TO BE CONFORMING TO THE MANUFACTURER SPECIFICATIONS. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. AS THE ISSUE COULD NOT BE REPRODUCED, A ROOT CAUSE WAS NOT DETERMINED. HOWEVER, BASED ON EVIDENCE FROM PREVIOUSLY INVESTIGATED CASES FOR SIMILAR ISSUES, SORIN GROUP ITALIA BELIEVES THE LIKELY ROOT CAUSE OF THE INCREASED PRESSURE DROP TO BE PLATELET ADHESION AND FIBRIN LAYER DEPOSITION INSIDE THE OXYGENATOR. THE MOST PROBABLE ROOT CAUSE OF PLATELET ADHESION AND FIBRIN DEPOSITION IS MULTI-FACTORIAL AND INCLUDES THE CLINICAL PROCEDURE (E.G SURGICAL MATERIAL), THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT SPECIFIC HEALTH CONDITIONS. THE EVENT DOES NOT APPEARS TO BE DEVICE-SPECIFIC.
SORIN GROUP (B)(4) RECEIVED A REPORT OF HIGH TRANSMEMBRANE PRESSURE AT THE INLET OF THE INSPIRE 6F DUAL HOLLOW FIBER OXYGENATOR DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER ON (B)(6) 2018, SORIN GROUP (B)(4) HAS BEEN INFORMED THAT THE PROCEDURE WAS PROLONGED FOR MORE THAT 30 MINUTES DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 841234 | INSPIRE 6F DUAL HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VEN/CARD RES | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | SORIN GROUP ITALIA SRL | 03704 | 1803290311 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |