FDA Adverse Event
Malfunction
Summary report: N
ECLIPSE HOMEPUMP
MDR report key: 7472398
·
Received April 27, 2018
Report
- Report Number
- MW5076871
- Event Type
- Malfunction
- Date Received
- April 27, 2018
- Date of Event
- April 9, 2018
- Report Date
- April 25, 2018
- Manufacturer
- HALYARD
- Product Code
- MEB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
ECLIPSE HOMEPUMP (MODEL # E252500, LOT # 0202891814) CONTAINING AZITHROMYCIN 500 MG IN 0.9 PERCENT SODIUM CHLORIDE 250 ML FILTER BROKE OFF AND WOULD NOT INFUSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313791 | ECLIPSE HOMEPUMP | ECLIPSE HOMEPUMP | MEB | HALYARD | E252500 | 0202891814 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |