FDA Adverse Event
Injury
Summary report: N
ALARIS PUMP MODULE MEDLEY GEMINI 3 VALVE
MDR report key: 2220449
·
Received August 17, 2011
Report
- Report Number
- MW5021806
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- August 17, 2011
- Report Date
- August 17, 2011
- Manufacturer
- ALARIS
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IV PUMP TUBING INFUSION INSULIN RUPTURED AT CASSETTE CONNECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE MEDLEY GEMINI 3 VALVE | IV PUMP TUBING | FPA | ALARIS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |