FDA Adverse Event
Other
Summary report: N
OUTLOOK 200
MDR report key: 778151
·
Received November 1, 2006
Report
- Report Number
- 1641965-2006-00036
- Event Type
- Other
- Date Received
- November 1, 2006
- Date of Event
- October 3, 2006
- Report Date
- October 30, 2006
- Manufacturer
- B. BRAUN MEDICAL, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
SEVERAL ATTEMPTS WERE MADE TO OBTAIN SUSPECT DEVICE FROM THE CUSTOMER WITHOUT SUCCESS. THE F/U REPORT WILL BE SUBMITTED ONCE EVAL IS DONE.
Description of Event or Problem · 1
THE DEVICE WAS SET TO DELIVER A SOLUTION OF AZTREONAM ANTIBIOTIC WITH A RATE OF 100CC/HR FOR 1 HR DELIVERY IN THE PIGGYBACK MODE. REPORTEDLY, THE BAG WAS EMPTIED IN 5-10 MINS. THE PT WAS NOT INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OUTLOOK 200 | INFUSION PUMP | FRN | B. BRAUN MEDICAL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |