FDA Adverse Event
Malfunction
Summary report: N
LIFESHIELD CONV SOLUSET
MDR report key: 1032898
·
Received April 23, 2008
Report
- Report Number
- 9615050-2008-00105
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- April 3, 2008
- Report Date
- April 3, 2008
- Manufacturer
- HOSPIRA DE COSTA RICA LTD.
- Product Code
- FPK
- PMA / PMN Number
- K912103
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED NO FLOW. THE SOLUSET WAS BEING USED TO DELIVER 1000ML OF LACTATED RINGER'S SOLUTION. IT WAS REPORTED THAT AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE SOLUTION WOULD NOT FLOW. THE SOLUSET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESHIELD CONV SOLUSET | 80-FPK | FPK | HOSPIRA DE COSTA RICA LTD. | NA | 451175H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |