FDA Adverse Event
Malfunction
Summary report: N
LIFESHIELD FILTER SOLUSET
MDR report key: 1002614
·
Received February 8, 2008
Report
- Report Number
- 9615050-2008-00030
- Event Type
- Malfunction
- Date Received
- February 8, 2008
- Date of Event
- January 1, 2008
- Report Date
- January 11, 2008
- Manufacturer
- HOSPIRA DE COSTA RICA LTD.
- Product Code
- FPB
- PMA / PMN Number
- K920736
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED AIR IN THE TUBING DISTAL TO THE SOLUSET. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED SOLUTION. THE CUSTOMER CONTACT REPORTED THAT AFTER THE SOLUSET EMPTIED, AIR WAS NOTED IN THE TUBING DISTAL TO THE SOLUSET. THE TUBING WAS CLAMPED. NO AIR WAS DELIVERED TO THE PT. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESHIELD FILTER SOLUSET | 80-FPB | FPB | HOSPIRA DE COSTA RICA LTD. | NA | 530675H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |