FDA Adverse Event
Malfunction
Summary report: N
F.A.S.T. 1
MDR report key: 561583
·
Received December 13, 2004
Report
- Report Number
- 561583
- Event Type
- Malfunction
- Date Received
- December 13, 2004
- Date of Event
- September 19, 2004
- Report Date
- September 22, 2004
- Manufacturer
- PYNG MEDICAL CORPORATION
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
Narratives
Description of Event or Problem · 1
THE PATIENT WAS TRANSFERRED TO THIS FACILITY WITH AN INTRAOSSEOUS INFUSION SYSTEM (IIS)INSERTED IN THE STERNUM. THE DEVICE IS DESIGNED NOT TO BE USED LONGER THAN 24 HOURS, DUE TO INFECTION. THE PATIENT ARRIVED WITHOUT THE STERNAL IV REMOVER. ALSO, THERE WAS NO ONE AT FACILITY'S THAT WAS FAMILIAR WITH THE IIS OR TRAINED TO REMOVE IT. A COMPANY REPRESENTATIVE WAS THEN CALLED IN TO EXTRICATE THE IIS. THE ATTEMPT TO REMOVE IT DID NOT WORK DUE TO THE FAILURE OF THE "REMOVER" TO ENGAGE THE INFUSION TUBE FROM THE BONE. THE PATIENT DIED OF UNRELATED CAUSES; OTHERWISE,THE PATIENT WOULD HAVE REQUIRED SURGICAL INTERVENTION TO REMOVE THE IIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | F.A.S.T. 1 | INTRAOSSEOUS INFUSION SYSTEM | FMI | PYNG MEDICAL CORPORATION | F.A.S.T. 1 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |