FDA Adverse Event
Malfunction
Summary report: N
INSPIRE 7F M N/S
MDR report key: 23907254
·
Received December 29, 2025
Report
- Report Number
- 9680841-2025-900044
- Event Type
- Malfunction
- Date Received
- December 29, 2025
- Date of Event
- November 24, 2025
- Report Date
- December 29, 2025
- Manufacturer
- SORIN GROUP ITALIA
- Product Code
- DTZ
- UDI-DI
- 803317811338
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
G.5. THE PRODUCT ITEM 03735 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 7 FM 050729 WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130209). H11 SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 7F M OXYGENATOR. THE EVENT OCCURRED IN DENMARK. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 0
SORIN GROUP ITALIA RECEIVED A REPORT THAT THE OXYGENATOR INSPIRE 7F WAS CHANGED OUT AFTER ONE HOUR OF USE, DUE TO HIGH PRESSURE INSIDE THE MEMBRANE. REPORTEDLY THE PATIENT HAD HISTORY OF LIVER CIRROSE, AND HEPARIN WAS ADMINISTRATED DUE TO LOW ACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1917819 | INSPIRE 7F M N/S | OXYGENATOR, CARDIOPULMONARY BYPASS | DTZ | SORIN GROUP ITALIA | 2509070009 (IN 2509040067) | 803317811338 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |