INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
Report
- Report Number
- 9680841-2019-00006
- Event Type
- Malfunction
- Date Received
- February 19, 2019
- Date of Event
- January 20, 2019
- Report Date
- April 19, 2019
- 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
SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 8 START P HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN MUENCHEN, 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 SORIN GROUP USA., INC. (IMPORTER). THE COMPLAINED OXYGENATOR WAS RETURNED TO SORIN ITALIA AND SUBJECTED TO LEAK TEST. THE TEST COULD NOT REPRODUCE ANY LEAK. THE FIBERS THAT CONSTITUTE THE HEAT EXCHANGER COMPARTMENT WERE UNROLLED AND VISUALLY INSPECTED. FEW FIBERS APPEARED FULL OF DRIED BLOOD, WHILE THEY ALL SHOULD BE COMPLETELY EMPTY. INSPECTION OF THE FIBERS, AFTER HAVING REMOVED THE DRIED BLOOD, REVEALED THE PRESENCE OF SUPERFICIAL DAMAGES THAT ARE NOT ATTRIBUTABLE TO ANY PROBLEM DURING SORIN ITALIA MANUFACTURING STEPS. LIVANOVA HAS INFORMED THE HEAT EXCHANGER FIBER SUPPLIER TO REQUEST ROOT CAUSE INVESTIGATION AND IMPLEMENTATION OF ADEQUATE CORRECTIVE ACTION. AS THE FREQUENCY OF THIS TYPE OF EVENT IS LOW, NO ACTION WILL BE UNDERTAKEN. LIVANOVA WILL MAINTAIN MONITOR THE MARKET.
THE COMPLAINED INSPIRE 8 START P OXYGENATOR (CATALOG NUMBER 050712, LOT 1808270007) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050712 IS SIMILAR TO THE INSPIRE 8 OXYGENATOR 050714, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF THE EVENT. (B)(4). THE PRODUCT ITEM 050712 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 8 OXYGENATOR 050714, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130433). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8 START P HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. THE REVIEW OF THE DEVICE HISTORY RECORD OF THE CLAIMED OXYGENATOR LOT CONFIRMED THAT THE DEVICE WAS RELEASED IN COMPLIANCE WITH MANUFACTURER SPECIFICATIONS. THE COMPLAINED OXYGENATOR WAS RETURNED AT SORIN (B)(4) FACILITIES AND SENT TO (B)(4) DECONTAMINATION AS PER LIVANOVA PROCEDURE ON BLOOD CONTAMINATED GOODS. VISUAL INSPECTION OF THE RETURNED OXYGENATOR FOUND RESIDUAL BLOOD IN THE WATER COMPARTMENT. AFTER EMPTYING THE RETURNED OXYGENATOR, THE BLOOD COMPARTMENT OF THE DEVICE WAS FILLED WITH WATER AND LEAK TESTED TO VERIFY THE POSSIBLE LEAKAGE BETWEEN THE WATER AND BLOOD COMPARTMENT. HOWEVER, NO LEAK COULD BE REPRODUCED. DESPITE NO LEAK COULD BE YET REPRODUCED, DEVICE IS STILL UNDER INVESTIGATION SINCE IT IS POSSIBLE THAT DRIED BLOOD IS OCCLUDING THE LEAKING POINT. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, AFTER A PROCEDURE, BLOOD WAS DETECTED IN THE WATER TANK OF THE HEATER-COOLER EQUIPMENT. ACCORDING TO INFORMATION THE PATIENT IS STABLE BUT CONTINUE TO REQUIRE VENTILATION AND DIALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142255 | INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | SORIN GROUP ITALIA SRL | 1808270007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |