FDA Adverse Event
Malfunction
Summary report: N
ECLIPSE HOMEPUMP
MDR report key: 6380649
·
Received March 2, 2017
Report
- Report Number
- MW5068275
- Event Type
- Malfunction
- Date Received
- March 2, 2017
- Date of Event
- March 1, 2017
- Report Date
- March 2, 2017
- Manufacturer
- HALYARD HEALTH, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
TWO ECLIPSE HOMEPUMPS FILLED WITH MEROPENEM 1 GRAM/NS 250 ML IN ECLIPSE HOMEPUMP 250 ML; 250 ML/HR, LOT 0202526792, MODEL # E252500 WOULD NOT INFUSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 153797 | ECLIPSE HOMEPUMP | PUMP, INFUSION | FRN | HALYARD HEALTH, INC. | E252500 | 0202526792 | |
| 153798 | ECLIPSE HOMEPUMP | PUMP, INFUSION | FRN | HALYARD HEALTH, INC. | E252500 | 0202526792 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |