INSPIRE 6F M DUAL HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES
Report
- Report Number
- 9680841-2018-00027
- Event Type
- Malfunction
- Date Received
- October 17, 2018
- Date of Event
- September 17, 2018
- Report Date
- January 25, 2019
- Manufacturer
- SORIN GROUP ITALIA SRL
- Product Code
- DTZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE INSPIRE 6F M DUAL HOLLOW FIBER OXYGENATOR IS 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 INTO WHICH THE OXYGENATOR WAS ASSEMBLED IS (B)(4). THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF EVENT. PER EXEMPTION NUMBER E2016005. THE INVOLVED INSPIRE 6F M HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050702) IS ALSO 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. (B)(6). THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION BUT NOT YET RETURNED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6F M DUAL HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN NEW YORK, NEW YORK. 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 EVALUATION. VISUAL INSPECTION IDENTIFIED NO DEFECTS OR NON-CONFORMITIES. BIOLOGICAL TRACES, BLOOD CLOTS AND BIOLOGICAL DEPOSITS, WERE FOUND IN THE INTEGRATED ARTERIAL FILTER. THE DEVICE WAS EXTENSIVELY RINSED, HOWEVER IT WAS NOT POSSIBLE TO REMOVE ALL BIOLOGICAL TRACES. THEREFORE, IT WAS NOT POSSIBLE TO SUBMIT THE DEVICE TO TRANSMEMBRANE PRESSURE VERIFICATION AS THE FLOWING OF WATER THROUGH THE DEVICE WAS IMPAIRED BY THE BIOLOGICAL DEPOSITS. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. BASED ON THE EVIDENCE OF DEVICE INSPECTION AND ON PREVIOUSLY INVESTIGATED SIMILAR CASES, SORIN GROUP ITALIA BELIEVES A 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 APPEAR TO BE DEVICE SPECIFIC.
SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE BLOOD FLOW THROUGH THE INSPIRE 6F M DUAL HOLLOW FIBER OXYGENATOR DROPPED FROM 4.5 LPM TO 2.5 LPM THREE MINUTES AFTER INITIATION OF CARDIOPULMONARY BYPASS. THERE WERE NO MODIFICATIONS MADE TO THE PUMP SPEED WHICH WOULD HAVE CAUSED THIS CHANGE. THE MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. THE PATIENT WAS VENTILATED. THERE WAS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 816207 | INSPIRE 6F M DUAL HOLLOW FIBER OXY W/ INTEGRATED HARDSHELL VENOUS CARDIOTOMY RES | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | SORIN GROUP ITALIA SRL | 1805030092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |