FDA Adverse Event
Malfunction
Summary report: N
RANGER PRESSURE INFUSER
MDR report key: 2232208
·
Received August 26, 2011
Report
- Report Number
- MW5021924
- Event Type
- Malfunction
- Date Received
- August 26, 2011
- Date of Event
- August 8, 2011
- Report Date
- August 26, 2011
- Manufacturer
- ARIZANT HEALTHCARE
- Product Code
- LGZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
RANGER PRESSURE INFUSER SET UP IN OPERATING ROOM FOR EMERGENCY CASE. RIGHT SIDE OF INFUSER NOT WORKING, LEFT SIDE WORKING BUT BLOOD BARELY RUNNING IN. ANOTHER RANGER PRESSURE INFUSER BROUGHT IN FROM ANOTHER HOSP DEPT, BOTH SIDES WORKING BUT BLOOD BARELY RUNNING IN. NO HARM OR ADVERSE OUT COME TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RANGER PRESSURE INFUSER | BLOOD INFUSER | LGZ | ARIZANT HEALTHCARE | 90032 | NA | |
| 2 | RANGER PRESSURE INFUSER | BLOOD INFUSER | KZD | ARIZANT HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR |