FDA Adverse Event
Malfunction
Summary report: N
SOLUSET VENTED 100 X 60
MDR report key: 1032897
·
Received April 23, 2008
Report
- Report Number
- 9615050-2008-00103
- Event Type
- Malfunction
- Date Received
- April 23, 2008
- Date of Event
- March 19, 2008
- Report Date
- April 2, 2008
- Manufacturer
- HOSPIRA DE COSTA RICA LTD
- Product Code
- FPA
- PMA / PMN Number
- K770743
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THE FLOAT VALVE IN THE SOLUSET DID NOT CLOSE WHEN THE SOLUSET EMPTIED. THE SOLUSET WAS BEING USED TO DELIVER 0.9% NORMAL SALINE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE FLOAT VALVE IN THE SOLUSET ADVERSE PT EFFECTS. NO MEDICAL INTERVENTION WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLUSET VENTED 100 X 60 | 80-FPA | FPA | HOSPIRA DE COSTA RICA LTD | NA | 581335G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |