FDA Adverse Event
Malfunction
Summary report: N
IV ADMINISTRATION SET
MDR report key: 1020753
·
Received March 17, 2008
Report
- Report Number
- 1221261-2008-00011
- Event Type
- Malfunction
- Date Received
- March 17, 2008
- Date of Event
- February 15, 2008
- Report Date
- February 19, 2008
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
USER ALLEGES THEY HAD ONE EVENT INVOLVING AN IV ADMINISTRATION SET THAT WHILE INFUSING BLOOD THE OVER TEMP ALARM SIGNALED. THE END USERS OBTAINED ANOTHER UNIT FROM THE OR AND SWITCHED THE D-100 DISPOSABLE SET FROM THE UNIT WHICH WAS OVER TEMPING TO THE OR UNIT. IN THE PROCESS OF SWITCHING THE DISPOSABLES, THE END USER NOTICED THAT BLOOD WAS LEAKING FROM THE H-1000 NEAR THE NUMBER 1 POSITION ON THE UNIT. THE DISPOSABLE WAS DISCARDED AND THE LOT # WAS NOT RECORDED. NO ADVERSE OUTCOME TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IV ADMINISTRATION SET | 80F-PA IV ADMINISTRATION SET | FPA | SMITHS MEDICAL ASD, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | H-1000 FAST FLOW FLUID BLOOD WARMER |