FDA Adverse Event
Malfunction
Summary report: N
ECLIPSE HOMEPUMP
MDR report key: 6673131
·
Received June 26, 2017
Report
- Report Number
- MW5070675
- Event Type
- Malfunction
- Date Received
- June 26, 2017
- Date of Event
- June 26, 2017
- Report Date
- June 26, 2017
- 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
UPON FILLING ECLIPSE HOMEPUMP (MODEL #E252500, LOT # 0008032539) WITH 0.9 PERCENT SODIUM CHLORIDE 120 ML, TECHNICIAN WAS UNABLE TO CLAMP TUBING AS IT IS THREADED INCORRECTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447413 | ECLIPSE HOMEPUMP | ECLIPSE HOMEPUMP | MEB | HALYARD | E252500 | 0008032539 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |