FDA Adverse Event
Injury
Summary report: N
OUTLOOK
MDR report key: 3032680
·
Received March 28, 2013
Report
- Report Number
- MW5029574
- Event Type
- Injury
- Date Received
- March 28, 2013
- Date of Event
- March 19, 2013
- Report Date
- March 28, 2013
- Manufacturer
- B. BRAUN
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IVS AND PAIN MEDICATION NEEDED AFTER SURGERY COULD NOT BE DELIVERED BECAUSE TWO (2) B BRAUN OUTLOOK 100 IV PUMPS WERE FREQUENTLY GOING INTO AN EMPTY BAG ALARM. THE PT WAS IN A LOT OF PAIN. TREATMENT WAS DELAYED. THE NURSE HAD TO FREQUENTLY HAVE TO RETURN TO RESTART THE IV PUMP. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 128349 | OUTLOOK | PUMP, IV, LARGEVOLUM | FRN | B. BRAUN | OUTLOOK 100 | NA | |
| 128350 | OUTLOOK 100 | PUMP, IV, LARGEVOLUME | FRN | B. BRAUN | OUTLOOK 100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Life Threatening | IV PUMP #2: B. BRAUN| OUTLOOK 100 IV PUMP, SERIAL NUMBER (B)(4) |