FDA Adverse Event
Malfunction
Summary report: N
OUTLOOK ES
MDR report key: 2151609
·
Received June 24, 2011
Report
- Report Number
- 1641965-2011-00038
- Event Type
- Malfunction
- Date Received
- June 24, 2011
- Date of Event
- May 18, 2011
- Report Date
- May 26, 2011
- Manufacturer
- B. BRAUN MEDICAL, INC.
- Product Code
- FRN
- PMA / PMN Number
- K011975
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVESTIGATION IS CURRENTLY UNDERWAY. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
INFUSED 100-200CC OF FLUID INTO THE FOREARM OF THE PT. THE FLUID WAS DRAINED, THE IV WAS REPOSITIONED AND THE PUMP WAS REPLACED. THE THERAPY WAS CONTINUOUS ON A RECENTLY ADMITTED FEMALE PT IN THE EMERGENCY ROOM. THE INCIDENT OCCURRED AT 10PM ON (B)(6) 2011. THE PT'S STATUS WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OUTLOOK ES | INFUSION PUMP | FRN | B. BRAUN MEDICAL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |