FDA Adverse Event
Malfunction
Summary report: N
OUTLOOK
MDR report key: 1843524
·
Received September 10, 2010
Report
- Report Number
- 1843524
- Event Type
- Malfunction
- Date Received
- September 10, 2010
- Date of Event
- July 31, 2010
- Report Date
- September 10, 2010
- Manufacturer
- B. BRAUN MEDICAL
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IN, US
Narratives
Description of Event or Problem · 1
BURETROL CHAMBER SQUEEZED BY RN TO FILL THE CHAMBER. MINIMAL PRESSURE APPLIED AND CHAMBER CRACKED IN MIDDLE OF CHAMBER AT PRINTED CALIBRATION SCALE. TUBING IMMEDIATELY DISCONNECTED FROM PATIENT AND ANOTHER BURETROL SET PRIMED AND PLACED ON IV. SECOND BURETROL SET PULLED LOOSE FROM LOWER Y SITE AND IMMEDIATELY DISCONTINUED. THIRD BURETROL SET OBTAINED, PRIMED AND ADDED TO IV. NO PROBLEMS NOTED WITH 3RD SET.====================== HEALTH PROFESSIONAL'S IMPRESSION====================== STAFF FEELS IT IS IN THE MANUFACTURING
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OUTLOOK | BURETROL | FPA | B. BRAUN MEDICAL | * | 61099703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 MO | NO OTHER THERAPIES |