FDA Adverse Event
Malfunction
Summary report: N
LEVEL 1 HOTLINE FLUID WARMING SET WITH GAS VENT
MDR report key: 2121421
·
Received May 6, 2011
Report
- Report Number
- 2183502-2011-00394
- Event Type
- Malfunction
- Date Received
- May 6, 2011
- Date of Event
- April 5, 2011
- Report Date
- May 4, 2011
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- LGZ
- PMA / PMN Number
- K911383
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A F/U REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DISPOSABLE DEVELOPED A LEAK THAT ALLOWED THE RECIRCULATING SOLUTION TO MIX WITH THE INFUSATE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEVEL 1 HOTLINE FLUID WARMING SET WITH GAS VENT | LGZ -- WARMER, THERMAL, INFUSION FLUID | LGZ | SMITHS MEDICAL ASD, INC. | NA | 1851848 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |