FDA Adverse Event
Injury
Summary report: N
ACCLAIM ENCORE INFUSION PUMP
MDR report key: 1950681
·
Received December 29, 2010
Report
- Report Number
- MW5018782
- Event Type
- Injury
- Date Received
- December 29, 2010
- Date of Event
- November 14, 2010
- Report Date
- December 29, 2010
- Manufacturer
- HOSPIRA
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
AFTER SETTING UP THE IV PUMP AND STARTING INFUSION, RN NOTED IV FLUID WAS NOT DRIPPING. THE PUMP WAS MAKING THE USUAL SOUND OF INFUSING AND THE IV FLUID VOLUME INFUSED NUMBER WAS INDICATED THAT FLUID WAS BEING INFUSED. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: PREGNANCY. INFUSION PUMP USED FOR IV FLUIDS AND IV ANTIBIOTICS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCLAIM ENCORE INFUSION PUMP | INFUSION PUMP | FRN | HOSPIRA | 12673983 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | Hospitalization |