FDA Adverse Event
Malfunction
Summary report: N
LEVEL 1 OTLINE FLUID WARMING SET
MDR report key: 3966442
·
Received May 29, 2014
Report
- Report Number
- 2183502-2014-00348
- Event Type
- Malfunction
- Date Received
- May 29, 2014
- Date of Event
- April 24, 2014
- Report Date
- May 29, 2014
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- LGZ
- PMA / PMN Number
- K911383
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE IS CURRENTLY BEING EVALUATED. THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. (B)(4).
Description of Event or Problem · 1
A REPORT WAS RECEIVED STATING THE DISPOSABLE DEVELOPED A LEAK THAT ALLOWED THE RECIRCULATING SOLUTION TO MIX WITH THE INFUSATE. THE DISPOSABLE WAS IMMEDIATELY DISCONNECTED AND REPLACED. NO PATIENT INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317502 | LEVEL 1 OTLINE FLUID WARMING SET | WARMER, THERMAL, INFUSION FLUID | LGZ | SMITHS MEDICAL ASD, INC. | NA | 2672484 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | LEVEL 1 HOTLINE FLUID WARMING UNIT |