FDA Adverse Event
Malfunction
Summary report: N
BAG ASSEMBLY, ADULT, BLOOD/FLUID
MDR report key: 2525461
·
Received March 30, 2012
Report
- Report Number
- 1313850-2012-00093
- Event Type
- Malfunction
- Date Received
- March 30, 2012
- Date of Event
- March 2, 2012
- Report Date
- March 2, 2012
- Manufacturer
- STRYKER CORP DBA GAYMAR
- Product Code
- LGZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT YET RETURNED TO MANUFACTURER FOR EVALUATION; FOLLOW-UP REPORT WILL BE ISSUED AS NECESSARY BASED UPON INVESTIGATION RESULTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT A FLUID WARMER CASSETTE WAS LEAKING. NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BAG ASSEMBLY, ADULT, BLOOD/FLUID | CASSETTE | LGZ | STRYKER CORP DBA GAYMAR | 11999-000 | 0212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |